Bioequivalence Study of Atazanavir 300 mg Capsule

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Atazanavir + Ritonavir

Intervention Type DRUG

Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.

B

Group Type ACTIVE_COMPARATOR

Atazanavir + Ritonavir

Intervention Type DRUG

Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.

Interventions

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Atazanavir + Ritonavir

Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.

Intervention Type DRUG

Atazanavir + Ritonavir

Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.

Intervention Type DRUG

Other Intervention Names

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Abilify Abilify

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes