Bioequivalence Study of Atazanavir 300 mg Capsule | NCT00393328

Studies
Bioequivalence Study of Atazanavir 300 mg Capsule

NCT00393328

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 8, 2011Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infections

Interventions

Atazanavir + Ritonavir
Atazanavir + Ritonavir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Oct 23, 2006

First Submission Date that Met QC Criteria

Oct 26, 2006

First Posted Date

Oct 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Atazanavir + Ritonavir
B	Active Comparator		Drug: Atazanavir + Ritonavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir + Ritonavir	Drug	Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Hamilton	New Jersey		United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718687	atazanavir, ritonavir drug combination
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided