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Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

NCT01404572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-06-10

Study results available
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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.

Conditions

Interventions

DRUG

Atazanavir (current formulation)

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

DRUG

Atazanavir, powder for oral use 1 (POU1)

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

DRUG

Atazanavir (POU2)

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01404572 on ClinicalTrials.gov