Tenofovir BE Study

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201611001870300
• Date of registration: 15/11/2016
• Prospective Registration: Yes
• Primary sponsor: Danadams Pharmaceutical Company Limited
• Public title: Tenofovir BE Study
• 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
• Date of first enrolment: 10/01/2017
• Target sample size: 30
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1870
• Study type: Interventional
• Study design: 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.
• Phase: Not Applicable

Countries of recruitment

Ghana

Contacts

• Name: Kwaku Poku Asante
• Affiliation: Head of Research

• Name: Dennis Adu-Gyasi
• Affiliation: Project Manager

Key inclusion & exclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.


Age minimum: 13 Year(s)
Age maximum: 18 Year(s)
Gender: Male

Health Condition(s) or Problem(s) studied

Antiretroviral Bioequivalence

Antiretroviral Bioequivalence

Intervention(s)

Cross-over

Primary Outcome(s)

Bioequivalence of the two investigational products

Source(s) of Monetary Support

Danadams Pharmaceutical Company Limited

Ethics review

Status: Approved
Approval date: 03/08/2015
Contact:

Kintampo HRC Institutional Ethics Committee

Status: Approved
Approval date: 11/08/2015
Contact:

GHANA HEALTH SERVICE ETHICAL REVIEW COMMITTEE