At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
Atazanavir +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Atazanavir, Cobicistat, and 1 other intervention for Human Immunodeficiency Virus Type 1 (HIV-1). Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedApr 2013
Primary CompletionJun 2013
TodayJul 2026
First PostedApr 23, 2013
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.2 years ago
Interventions
Atazanavirdrug
300-mg capsule
Cobicistatdrug
150-mg tablet
Atazanavir/Cobicistat FDCdrug
Atazanavir 300-mg/cobicistat 150-mg FDC tablet