NCT01837719

Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

A Randomized, 5-Period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Following a Light Meal, the Relative Bioavailability of Atazanavir When Co-Administered With Cobicistat as a Fixed Dose Combination Relative to the Single Agents Under Fasted Conditions, and the Effect of Food on the Bioavailability of Atazanavir in the Fixed Dose Combination

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.

Conditions

• Human Immunodeficiency Virus Type 1 (HIV-1)

Interventions

Type	Name	Description
DRUG	Atazanavir	300-mg capsule
DRUG	Cobicistat	150-mg tablet
DRUG	Atazanavir/Cobicistat FDC	Atazanavir 300-mg/cobicistat 150-mg FDC tablet

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-04-23
• Last updated: 2014-08-29
• Results posted: 2014-08-29

Locations

1 site across 1 country: United States