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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001870300 Date of Approval: 15/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tenofovir BE Study
Official scientific title A Balanced, Randomized, Two Treatment, Two-Period, Two-Sequence Single Dose Crossover, Open-Label, Analyst Blind And Single Centre Bioequivalence Study Test Product; Tenofevek Of Danadams Pharmaceuticals Industry Ltd., Ghana And Reference Product; Viread (Gilead Sciences, Inc., CA, USA) In Healthy, Ghanaian Adult, Male, Human Participants Under Fasting Conditions
Brief summary describing the background and objectives of the trial An open label, balanced, randomized, two-treatment, two-sequence, two-period, cross-over, comparative bioavailability study of test product and reference product in healthy, adult, male, human participants under fasting conditions; 1. To assess the oral bioavailability of test product; ¿Tenofovek 300mg Tablet (containing Tenofovir 300mg) of Danadams Pharmaceuticals Industry Ltd., Ghana with reference product; Viread 300mg Tablet (containing Tenofovir 300mg) of Gilead Sciences, Inc., CA, USA in healthy, adult, male, human participants under fasting condition. 2. To monitor the safety and tolerability of the test product as compared to the reference product in healthy, human participants. We plan using 30 (28 + 2 standby) participants
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BESTUDY
Disease(s) or condition(s) being studied Antiretroviral Bioequivalence
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/01/2017
Actual trial start date 31/01/2017
Anticipated date of last follow up 10/03/2017
Actual Last follow-up date 08/03/2017
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 28
Recruitment status Not yet recruiting
Publication URL
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 of participants to recruit into the clinic. Treatment will be given in blocks of 6 at a time where half will receive the study product and the other half the comparator product. Sealed enveloped pre-packed with numbers linked to the study products. It is only by the code one will know which product has been given to a participant. Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cross-over single dose of each of the treatment Two period each of 24 hours monitoring Each participant takes each of the two treatment and return after the wash out period for the second treatment. Each treatment could be any of the investigational drugs. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants with following criteria will be included into the study: 1. Healthy males within 18-35 years of age (both inclusive) 2. Weight at least 35 kg and BMI in the range of 18.5 ¿ 24.9 kg/m2 (both inclusive). 3. Normal health as determined by medical history and clinical examination, laboratory or other tests (mentioned in sections 8.4.II, 8.4.III) within normal range 4. Willingness to provide voluntary written informed consent to participate in the study, ability to comprehend the nature and purpose of the study 5. Willingness to comply with the requirement of the protocol including all the restrictions. 6. Availability of participant for the entire study period 1. History of allergy or hypersensitivity to Investigational Product. 2. Abnormalities in vital signs (systolic blood pressure < 90 or > 140 mm Hg or diastolic blood pressure < 50 or > 90 mm Hg or heart rate < 50 bpm or > 100 bpm) at screening, at pre-entry and at pre-dose physical examination. 3. Clinically significant cardiovascular, gastrointestinal, liver, renal, pulmonary, haematological, neurological, endocrinal disease. 4. History of epilepsy or psychiatric or CNS disorder. 5. Any illness within 21days or hospitalized or a major illness within the 3 months prior to the first dosing. 6. Any other clinical condition, which may affect the absorption, distribution, biotransformation or excretion of the study drug. (eg. diarrhoea, vomiting in 3 days prior to or at dosing). 7. Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing. 8. Participated in any other clinical investigation requiring repeated blood sampling/a blood donation program / have blood loss of more than 350 mL in the past three months. 9. History of consumption of alcohol for more than two years & drink more than two alcoholic drinks per day or consumed alcohol within 72 hours prior to first dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, and one measure i.e. one fluid ounce of spirit)]. 10. Smoke more than 10 cigarettes/day or Unable to abstain from smoking during the study. 11. Consumption of products containing xanthine & nicotine within 72 hours before dosing. 12. Intake of grapefruits or products containing grapefruits within 72 hours prior to receiving the dose of study medication in each period. 13. An unusual diet, for whatever reason (e. g. low-sodium or high protein) for four weeks prior to receiving the study medication. 14. Use of any recreational drug or a history of drug addiction. 15. Participation in any clinical study within the past 3 months. 16. History of difficulty in accessibility of veins in arms. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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
Yes 11/08/2015 GHANA HEALTH SERVICE ETHICAL REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Research & Development Division Ghana Health Service P. O. Box MB 190 Accra. Accra NA Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/08/2015 Kintampo HRC Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Box 200 Kintampo, Brong-Ahafo NA Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bioequivalence of the two investigational products AT the end of the analysis of the two period treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kintampo Health Research Centre Clinic Box 200 Kintampo North NA Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Danadams Pharmaceutical Company Limited TS 73, Teshie Accra NA Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Danadams Pharmaceutical Company Limited TS 73, Teshie Accra NA Ghana Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University of Southern California 1985 Zonal Avenue Los Angeles, Los Angeles CA 90033 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seth Owusu-Agyei seth.owusu-agyei@kintampo-hrc.org +233-57-760-3239 box 200
City Postal code Country Position/Affiliation
Kintampo North NA Ghana Director/PI
Role Name Email Phone Street address
Public Enquiries Dennis Adu-Gyasi dennis.adu-gyasi@kintampo-hrc.org +233207028698 box 200
City Postal code Country Position/Affiliation
Kintampo North NA Ghana Project Manager
Role Name Email Phone Street address
Scientific Enquiries Kwaku Poku Asante kwakupoku.asante@kintampo-hrc.org +233-57-760-3239 box 200
City Postal code Country Position/Affiliation
Kintampo North NA Ghana Head of Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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