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Drug Interaction Study With Proton Pump Inhibitor

NCT00357240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

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 omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.

Conditions

  • HIV Infections

Interventions

DRUG

Atazanavir

Capsules, Oral, 400 mg, once daily, 6 days.

DRUG

Atazanavir/Ritonavir

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

DRUG

Atazanavir

Capsules, Oral, 400 mg, once daily, 6 days.

DRUG

Atazanavir/Ritonavir

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.

DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-08-31
Completion
2006-08-31

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 NCT00357240 on ClinicalTrials.gov