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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00393328 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Atazanavir + Ritonavir |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
Official Title: | Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects |
Estimated Enrollment: | 46 |
Study Start Date: | November 2006 |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Atazanavir + Ritonavir
Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.
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B: Active Comparator |
Drug: Atazanavir + Ritonavir
Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study ID Numbers: | AI424-282 |
Study First Received: | October 23, 2006 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00393328 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Atazanavir Aripiprazole Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |