NCT03309566

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

Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2016-09-04
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2017-10-13
• Last updated: 2017-10-13

Locations

1 site across 1 country: Argentina