NCT00393328CompletedPhase 1
Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects
Bristol-Myers Squibb1 site in 1 country46 target enrollmentStarted: November 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A
Active Comparator
Intervention: Atazanavir + Ritonavir (Drug)
B
Active Comparator
Intervention: Atazanavir + Ritonavir (Drug)
Outcomes
Primary Outcomes
Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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