Bioequivalence Study of Atazanavir 300 mg Capsule

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Atazanavir + Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393328

AI424-282

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

46 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Atazanavir + Ritonavir

Drug: Atazanavir + Ritonavir

B

Active Comparator group

Treatment:

Drug: Atazanavir + Ritonavir

Drug: Atazanavir + Ritonavir