Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir

NCT03309566 | Completed Phase 4

• 1 other identifier: PRO-BEQ-EET-002-V.01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration

  192 hours

• AUC

  Area under the curve

  192 hours

Secondary Outcomes (1)

• Adverse events

  192 hours

Study Arms (2)

Test - Reference

EXPERIMENTAL

A new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R).

Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine

Reference - Test

EXPERIMENTAL

A branded formulation (R) followed by a new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T).

Drug: Efavirenz, tenofovir disoproxil fumarate and emtricitabine

Interventions

Efavirenz, tenofovir disoproxil fumarate and emtricitabine DRUG

Two period administration of a formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.

Reference - Test; Test - Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects between 18 and 55 years. Subjects with body mass index (BMI) between 19 and 27 kg / m². Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator.
• 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.
• Subjects who signed informed consent.

You may not qualify if:

• Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.
• 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.
• Active smoker more than 10 cigarettes / day. Pregnant or lactating women. Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).
• Current clinical evidence of kidney disease. Current evidence of liver disorders Current clinical evidence of respiratory and heart diseases. The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.
• Evidence of gastroduodenal disease. Current presence of any malignancy. History of abuse or addiction to drugs or alcohol during the past three years. Participation in a clinical trial within the last three months. Use of any drug within fourteen days before the start of the study. 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.
• 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).
• ECG abnormalities. Positive serology for HIV, hepatitis B or hepatitis C.

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead

Study Sites (1)

DominguezLab

Paraná, Entre Ríos Province, 3102, Argentina

Location

MeSH Terms

Interventions

efavirenz; Tenofovir; Emtricitabine

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• María C Fritz, MD

  DominguezLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, two-way crossover.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: September 4, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)