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

NCT ID: NCT03309566

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-04

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-dose, two-way crossover.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test - Reference

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).

Group Type EXPERIMENTAL

Efavirenz, tenofovir disoproxil fumarate and emtricitabine

Intervention Type 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

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).

Group Type EXPERIMENTAL

Efavirenz, tenofovir disoproxil fumarate and emtricitabine

Intervention Type DRUG

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

Interventions

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Efavirenz, tenofovir disoproxil fumarate and emtricitabine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratorio Elea Phoenix S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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María C Fritz, MD

Role: PRINCIPAL_INVESTIGATOR

DominguezLab

Locations

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DominguezLab

Paraná, Entre Ríos Province, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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PRO-BEQ-EET-002-V.01

Identifier Type: -

Identifier Source: org_study_id