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Bioequivalence Study of Atazanavir 300 mg Capsule

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ClinicalTrials.gov Identifier: NCT00393328
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir + Ritonavir Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects
Study Start Date : November 2006
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A Drug: Atazanavir + Ritonavir
Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.
Other Name: Abilify
Active Comparator: B Drug: Atazanavir + Ritonavir
Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.
Other Name: Abilify


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393328


Locations
United States, New Jersey
Local Institution
Hamilton, New Jersey, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00393328     History of Changes
Other Study ID Numbers: AI424-282
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: June 2008

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Aripiprazole
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs