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

Acquired Immunodeficiency Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583464
• Other study ID #: BE-TNF-EMT
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2015
• Last updated: October 20, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Laboratorio Elea S.A.C.I.F. y A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.

Description:

A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was followed by a 7-day washout period. Blood samples were collected at baseline and 0.25, 0.50, 0.75, 1, 1.25, 1.5 2, 2.5, 3, 4, 7, 12, 24 and 48 h after administration. Emtricitabine and tenofovir concentrations were determined using a validated LC (liquid chromatography) - MS (mass spectrometry) / MS method. Adverse events were monitored based on clinical parameters and volunteer reports.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Tenofovir disoproxil fumarate and emtricitabine
Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.

Locations

Country	Name	City	State
Argentina	Laboratorio Elea SACIFyA	Capital Federal	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorio Elea S.A.C.I.F. y A.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration [Cmax]		48 hours	No
Primary	Area Under the Curve [AUC]		48 hours	No
Secondary	Adverse events		48 hours	Yes