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

NCT02583464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-10-22

No results posted yet for this study

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.

Conditions

  • Acquired Immunodeficiency Syndrome

Interventions

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.

Sponsors & Collaborators

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Principal Investigators

  • Guillermo Di Girolamo, MD · Centro de la Asociación Mutual de Profesionales del Hospital Italiano

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583464 on ClinicalTrials.gov