Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607847734586 Date of Registration: 21/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Bioequivalence of Enalapril Tablets Dawapril® 10mg by Dawa Life Sciences, Kenya with Ena-denk® 10mg by Denk Pharma, Germany.
Official scientific title Bioequivalence of a Locally Manufactured Brand of Enalapril 10mg Tablet: A Randomized, Open-Label, Non-Replicated, Two-Sequence, Two-Period Crossover Pilot Study for the Introduction of Bioequivalence Studies in East Africa
Brief summary describing the background and objectives of the trial Enalapril is listed as essential medicine by the World Health Organization (WHO) used in treatment of cardiovascular and renal diseases. It was originally developed by Merck as a second-generation angiotensin converting enzyme inhibitor. From early 2000s, generic molecules have been made by several other pharmaceutical companies. According to WHO prequalification of medical products, generic products must meet same safety, quality and efficacy standards as that of original molecules and be clinically interchangeable or therapeutically equivalent to the innovator product. This study aims to assess the bioequivalence (BE) of a locally manufactured brand of enalapril 10mg tablet as a pilot for introduction of BE studies in East Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BELME/EA Study
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial BIOEQUIVALENCE STUDY
Anticipated trial start date 01/07/2026
Actual trial start date 01/07/2026
Anticipated date of last follow up 31/08/2026
Actual Last follow-up date 31/08/2026
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
Recruitment status Not yet recruiting
Publication URL Pending as publication is yet to be done
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enalapril 10 mg tablets Dawapril Brand by Dawa Life sciences Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2 One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2 Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2 8
Control Group Enalapril 10mg tablets EnaDenk brand by Denk Pharma Participants in this group will receive a single dose of the reference drug-Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then the test drug, Dawapril® 10mg tablets by Dawa Life Sciences, Kenya (a single dose Enalapril generic brand ) during period 2. There is a wash out period of 8 days between period 1 and period 2. One day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2. Group 2 participants will receive a single dose of Ena-denk® 10mg tablets during period 1; then a single dose of Dawapril® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Biological male sex 2. Age between 18 to 55 years (both inclusive) 3. Has a BMI of 20 to 30 kg/m2 (both inclusive) 4. Willing and able to provide informed consent 1. History of drug abuse or alcohol abuse. 2. Current medical treatment or treatment in the last one week. 3. Current acute or chronic illness 4. Laboratory findings suggestive of liver disease, kidney disease, blood disorder or systemic infection 5. Currently enrolled in another interventional trial with an investigational product. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/04/2026 AMREF ETHICS AND SCIENTIFIC REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
LANGATA ROAD NAIROBI 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maximum plasma concentration (Cₘₐₓ) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC₀₋ₜ) and extrapolated to infinity (AUC₀₋∞) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet. 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product while from 0.5 onwards is post-administration of study product
Secondary Outcome Time to reach maximum concentration (Tₘₐₓ) of enalapril and enalaprilat, and safety and tolerability assessed through adverse event monitoring. 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product while from 0.5 onwards is post-administration of study product
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SANEL HOSPITAL MLOLONG0 MOMBASA ROAD Nairobi 00620 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
PENAM LIMITED JEMPARK BUILDING, MOMBASA ROAD Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KENYA MEDICAL RESEARCH INSTITUTE OFF RAILA ODINGA ROAD NAIROBI 00200 Kenya GOVERMENT RESEARCH AGENCY
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JOEL OJWANDO jojwando@gmail.com +254721441177 MOMBASA ROAD
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya MEDICAL SPECIALIST
Role Name Email Phone Street address
Public Enquiries Isaac Githaiga isaac.githaiga@penamlimited.com +254722833143 MOMBASA ROAD
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya DIRECTOR
Role Name Email Phone Street address
Scientific Enquiries DISMAS OKETCH wuonnyamor@gmail.com +254720473785 MOMBASA ROAD
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya PHYSICIAN INVESTIGATOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigator and the sponsor are committed to responsible data sharing and making IPD available for research purposes. The sharing will be strictly with the relevant stakeholders. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 years after end of study Will be shared
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Will be shared No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 19/05/2026 Change in approval timelines 01 May 2026 01 Jul 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 19/05/2026 Change in approval timelines 01 Jul 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 19/05/2026 Change in approval timelines 30 Jun 2026 31 Aug 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 19/05/2026 Change in approval timelines 31 Aug 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 19/05/2026 Change in approval timelines 16
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 19/05/2026 no change Pending as publication is yet to be done
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 04/04/2026 for clarification of eligibility age of 18 to 55 years. Adult: 18 Year(s)-44 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/04/2026 for clarification as requested Experimental Group, Test group, 10MG , 1 day, Sequence 1 particiants will receive the test drug during period 1 and experimental drug uring period 2. , 8, Experimental Group, Test group, Single dose Enalapril generic brand Ena-denk® 10mg by Denk Pharma, Germany, during period 1; then aa single does local brand Dawapril® 10mg by Dawa Life Sciences, Kenya, duirng period 2, 1 day treatement duirng period 1 and another day treatment during period 2, Sequence 1 particiants will receive the test drug during period 1 and experimental drug uring period 2. , 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/05/2026 To Clarify Intervention name , Dose, Duration and intervention description Experimental Group, Test group, Single dose Enalapril generic brand Ena-denk® 10mg by Denk Pharma, Germany, during period 1; then aa single does local brand Dawapril® 10mg by Dawa Life Sciences, Kenya, duirng period 2, 1 day treatement duirng period 1 and another day treatment during period 2, Sequence 1 particiants will receive the test drug during period 1 and experimental drug uring period 2. , 8, Experimental Group, Sequence 1 , Participants will receive Single dose of Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then a single does local brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Sequence 1 participants will receive Ena-denk® 10mg tablets during period 1 and Dawapril® tablets 10mg during period 2. there is a wash out period of 8 days between period 1 and period 2, 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 19/05/2026 To Clarify Intervention name , Dose, Duration and intervention description Experimental Group, Sequence 1 , Participants will receive Single dose of Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then a single does local brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Sequence 1 participants will receive Ena-denk® 10mg tablets during period 1 and Dawapril® tablets 10mg during period 2. there is a wash out period of 8 days between period 1 and period 2, 8, Experimental Group, Sequence 1 Reference then Test group, Participants will receive Single dose of Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then a single does local brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Sequence 1 participants will receive Ena-denk® 10mg tablets during period 1 and Dawapril® tablets 10mg during period 2. there is a wash out period of 8 days between period 1 and period 2, 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2026 To Clarify Intervention name , Dose, Duration and intervention description Experimental Group, Enalapril 10 mg tablets, Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2, 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/07/2026 To Clarify Intervention name , Dose, Duration and intervention description Experimental Group, Enalapril 10 mg tablets, Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2, 8, Experimental Group, Enalapril 10 mg tablets by Dawa Life sciences, Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2, 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/07/2026 To Clarify Intervention name , Dose, Duration and intervention description Experimental Group, Enalapril 10 mg tablets by Dawa Life sciences, Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2, 8, Experimental Group, Enalapril 10 mg tablets Dawapril Brand by Dawa Life sciences, Participants will receive a single dose of enalapril generic brand Dawapril® tablets 10mg by Dawa Life Sciences, Kenya, during period 1; then a single dose of Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, One day during period 1 and another one day treatment during period 2; there is a wash out period of 8 days between period 1 and period 2, Group 1 participants will receive Dawapril® 10mg tablets during period 1 and Ena-denk® tablets 10mg during period 2 with a wash out period of 8 days between period 1 and period 2, 8,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/04/2026 for clarification as requested Control Group, Reference group, 10mg, 1, Reference group will receive test drug during period 1 and the refrence drug during period 2, 8, Active-Treatment of Control Group Control Group, Reference group, A single does local brand Dawapril® 10mg by Dawa Life Sciences, Kenya, duirng period 1; then a single dose Enalapril generic brand Ena-denk® 10mg by Denk Pharma, Germany, during period 2, 1 day treatment during period 1 and another day treatment during period 2, Reference group will receive test drug during period 1 and the refrence drug during period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/05/2026 To Clarify on Intervention name ,Dose and intervention description Control Group, Reference group, A single does local brand Dawapril® 10mg by Dawa Life Sciences, Kenya, duirng period 1; then a single dose Enalapril generic brand Ena-denk® 10mg by Denk Pharma, Germany, during period 2, 1 day treatment during period 1 and another day treatment during period 2, Reference group will receive test drug during period 1 and the refrence drug during period 2, 8, Active-Treatment of Control Group Control Group, Sequence 2, Participants will receive a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya, during period 1; then a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 19/05/2026 To Clarify on Intervention name ,Dose and intervention description Control Group, Sequence 2, Participants will receive a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya, during period 1; then a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group Control Group, Sequence 2 Test then Reference group, Participants will receive a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya, during period 1; then a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/06/2026 To Clarify on Intervention name ,Dose and intervention description Control Group, Sequence 2 Test then Reference group, Participants will receive a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya, during period 1; then a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 2. There is a wash out period of 8 days between period 1 and period 2, one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group Control Group, Sequence 2 Test then Reference group, Participants in this group will receive the test drug (a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya) during period 1; then the Reference drug (a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany) during period 2. There is a wash out period of 8 days between period 1 and period 2. This arm will also receive both the test and reference drug in the order of Test then Reference., one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 06/07/2026 To Clarify on Intervention name ,Dose and intervention description Control Group, Sequence 2 Test then Reference group, Participants in this group will receive the test drug (a single dose of local brand Dawapril® 10mg tablets by Dawa Life Sciences, Kenya) during period 1; then the Reference drug (a single dose Enalapril generic brand Ena-denk® 10mg tablets by Denk Pharma, Germany) during period 2. There is a wash out period of 8 days between period 1 and period 2. This arm will also receive both the test and reference drug in the order of Test then Reference., one day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2, Sequence 2 participants will receive a single dose of Dawapril® 10mg tablets during period 1; then a single dose Ena-denk® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group Control Group, Enalapril 10mg tablets, Participants in this group will receive a single dose of the reference drug-Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then the test drug, Dawapril® 10mg tablets by Dawa Life Sciences, Kenya (a single dose Enalapril generic brand ) during period 2. There is a wash out period of 8 days between period 1 and period 2. , One day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2., Group 2 participants will receive a single dose of Ena-denk® 10mg tablets during period 1; then a single dose of Dawapril® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/07/2026 To Clarify on Intervention name ,Dose and intervention description Control Group, Enalapril 10mg tablets, Participants in this group will receive a single dose of the reference drug-Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then the test drug, Dawapril® 10mg tablets by Dawa Life Sciences, Kenya (a single dose Enalapril generic brand ) during period 2. There is a wash out period of 8 days between period 1 and period 2. , One day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2., Group 2 participants will receive a single dose of Ena-denk® 10mg tablets during period 1; then a single dose of Dawapril® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group Control Group, Enalapril 10mg tablets EnaDenk brand by Denk Pharma, Participants in this group will receive a single dose of the reference drug-Ena-denk® 10mg tablets by Denk Pharma, Germany, during period 1; then the test drug, Dawapril® 10mg tablets by Dawa Life Sciences, Kenya (a single dose Enalapril generic brand ) during period 2. There is a wash out period of 8 days between period 1 and period 2. , One day during period 1 and another one day during period 2.There is a wash out period of 8 days between period 1 and period 2., Group 2 participants will receive a single dose of Ena-denk® 10mg tablets during period 1; then a single dose of Dawapril® 10mg tablets during period 2.There is a wash out period of 8 days between period 1 and period 2, 8, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/04/2026 To clarify the time points as requested- time point 0 is before administration of study product while the rest are post administration of the study product. Primary Outcome, Maximum plasma concentration (Cₘₐₓ) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC₀₋ₜ) and extrapolated to infinity (AUC₀₋∞) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet., 0 , 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 Primary Outcome, Maximum plasma concentration (Cₘₐₓ) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC₀₋ₜ) and extrapolated to infinity (AUC₀₋∞) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet., 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product whle from 0.5 onwards is post-administration of study product
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/04/2026 To clarify the time points as requested- time point 0 is before administration of study product while the rest are post administration of the study product. Primary Outcome, Maximum plasma concentration (Cₘₐₓ) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC₀₋ₜ) and extrapolated to infinity (AUC₀₋∞) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet., 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product whle from 0.5 onwards is post-administration of study product Primary Outcome, Maximum plasma concentration (Cₘₐₓ) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC₀₋ₜ) and extrapolated to infinity (AUC₀₋∞) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet., 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product while from 0.5 onwards is post-administration of study product
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/04/2026 To provide clarification as requested. Time 0-is pre- admnistration of the study product while the rest are post-administration of study product Secondary Outcome, Time to reach maximum concentration (Tₘₐₓ) of enalapril and enalaprilat, and safety and tolerability assessed through adverse event monitoring., 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 Secondary Outcome, Time to reach maximum concentration (Tₘₐₓ) of enalapril and enalaprilat, and safety and tolerability assessed through adverse event monitoring., 0, 0.5, 1.0, 1.5, 2.25, 3, 3.75, 5, 8, 12, 24 0-is pre- admnistration of the study product while from 0.5 onwards is post-administration of study product
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 01/05/2026 Revise Grammar The investigator nad the sponsor are committed to reponsible data sharing and making IPD availabe for resach purposes. The sharing will be strictly with the relevant stakeholders. The investigator and the sponsor are committed to responsible data sharing and making IPD available for research purposes. The sharing will be strictly with the relevant stakeholders.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 01/05/2026 To comply with 12 months guideline 2 years after end of study 1 years after end of study
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 01/05/2026 No change will be shared Will be shared
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 01/05/2026 to Complete section Will be shared