CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Atazanavir (current formulation) +2 moredrug
Likely dose
Atazanavir (current formulation) 15 mgfrom 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.

Search/NCT01404572
NCT01404572Phase 1Completed
CompareCT.gov

Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects

Bristol-Myers Squibb·interventional·Posted Jul 28, 2011·Updated Jun 10, 2013

In Brief

A Phase 1 clinical trial evaluating Atazanavir (current formulation), Atazanavir, powder for oral use 1 (POU1), and 1 other intervention for HIV. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.9 years ago

Interventions

Atazanavir (current formulation)drug

Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose

Atazanavir, powder for oral use 1 (POU1)drug

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose

Atazanavir (POU2)drug

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose