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Bioequivalence Study of Atazanavir 300 mg Capsule

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00393328
First Posted: October 27, 2006
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
October 23, 2006
October 27, 2006
April 8, 2011
November 2006
December 2006   (Final data collection date for primary outcome measure)
Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study
Same as current
Complete list of historical versions of study NCT00393328 on ClinicalTrials.gov Archive Site
  • 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
  • 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 PE, VS, ECG and clinical laboratory tests will be collected at study discharge
Not Provided
Not Provided
 
Bioequivalence Study of Atazanavir 300 mg Capsule
Bioequivalence Study of Atazanavir Single 300 mg Capsule Relative to Two Atazanavir 150 mg Capsules in Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
HIV Infections
  • 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
  • Drug: Atazanavir + Ritonavir
    Capsules, Oral, ATV 300mg as single cap + RTV 100mg, single dose, 7 days washout.
    Other Name: Abilify
  • Active Comparator: A
    Intervention: Drug: Atazanavir + Ritonavir
  • Active Comparator: B
    Intervention: Drug: Atazanavir + Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00393328
AI424-282
Not Provided
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP