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Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

NCT00362726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-04-08

No results posted yet for this study

Summary

The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Conditions

  • HIV Infections

Interventions

DRUG

Rosiglitazone maleate

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

DRUG

Atazanavir Sulphate

Capsules, Oral, ATV 400 mg, once daily, 5 days.

DRUG

Atazanavir Sulphate + Rosiglitazone maleate

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

DRUG

Atazanavir Sulphate + Ritonavir

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.

DRUG

Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate

Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362726 on ClinicalTrials.gov