Bioequivalence Study of Atazanavir 300 mg Capsule

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanavir + Ritonavir

• Registration Number: NCT00393328
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to assess the bioequivalence of atazanavir administered as a single 300 mg capsule relative to two atazanavir 150 mg capsules in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-27
• Study Start: 2006-11
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-06
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 30 kg/m²
• Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Atazanavir + Ritonavir	-
A	Atazanavir + Ritonavir	-

Primary Outcome Measures

Name	Time	Method
Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study

Secondary Outcome Measures

Name	Time	Method
Blood ritonavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study
Safety parameters including physical exam (PE), vital signs (VS), electrocardiogram (ECG) and clinical laboratory tests will be collected at study discharge

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Hamilton, New Jersey, United States