Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Status and phase
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Details and patient eligibility
About
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.
Full description
This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key inclusion criteria:
- Healthy men and women, ages 18 to 49, inclusive
- Nonsmokers
- Women not pregnant or breastfeeding
- Participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening
Key exclusion criteria:
- Any significant acute or chronic medical illness
- Any acute or chronic condition that may have altered taste sensory perception
- Any major surgery or trauma within 4 weeks of Day 1
- Blood transfusion within 4 weeks of study participation
- Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse
- Positive urine drug screen
- Positive urine screen for cotinine
- Positive hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibodies
- Clinically significant elevations in results of liver function tests above normal range
Trial design
12 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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