Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT02583464
• Date of registration: 19/10/2015
• Prospective Registration: No
• Primary sponsor: Laboratorio Elea S.A.C.I.F. y A.
• Public title: Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
• Scientific title: Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
• Date of first enrolment: September 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02583464
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Argentina

Contacts

• Name: Guillermo Di Girolamo, MD
• Affiliation: Centro de la Asociación Mutual de Profesionales del Hospital Italiano

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects of both sexes between 21 and 55 years.

2. Subjects with body mass index (BMI) between 19 and 27 kg / m².

3. Subjects whose complementary tests (ECG, blood and urine) are within normal and / or
clinically insignificant according to the judgment of the investigator. Women of
childbearing age should have a negative pregnancy test and use a reliable method of
contraception during the study (IUD or condoms)

4. Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic
pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.

5. Subjects who signed informed consent.

Exclusion Criteria:

1. Background of clinically significant allergies (except untreated asymptomatic
seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component
of the formulations studied.

2. Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic
pressure in the first 3 minutes of postural change.

3. Active smoker more than 10 cigarettes / day.

4. Pregnant or lactating women.

5. Current clinical evidence of severe digestive disorders, surgery of the digestive
tract (except appendectomy).

6. Current clinical evidence of kidney disease.

7. Current evidence of liver disorders

8. Current clinical evidence of respiratory and heart diseases.

9. The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.

10. Evidence of gastroduodenal disease.

11. Current presence of any malignancy.

12. History of abuse or addiction to drugs or alcohol during the past three years.

13. Participation in a clinical trial within the last three months.

14. Use of any drug within fourteen days before the start of the study.

15. Subject donated or suffered blood loss during the last twelve weeks before the start
of the study, or intends to donate blood within three months of the completion of the
study.

16. Excessive drinking of tea, cocoa, mate, coffee and / or beverages containing caffeine
(> 5 cups / day) or wine (> 0.5 L / day) or alcohol (> 50 ml / day).

17. ECG abnormalities.

18. Positive serology for HIV, hepatitis B or hepatitis C.

19. Women who are not using effective contraception (IUD, condom)



Age minimum: 21 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acquired Immunodeficiency Syndrome

Intervention(s)

Drug: Tenofovir disoproxil fumarate and emtricitabine

Primary Outcome(s)

Maximum Plasma Concentration [Cmax] [Time Frame: 48 hours]

Area Under the Curve [AUC] [Time Frame: 48 hours]

Secondary Outcome(s)

Adverse events [Time Frame: 48 hours]

Secondary ID(s)

BE-TNF-EMT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors