Drug Interaction Study With Proton Pump Inhibitor

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: Atazanavir/Ritonavir+Omeprazole

Drug: Atazanavir/Ritonavir

Drug: Atazanavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00357240

AI424-288

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2

Trial design

56 participants in 8 patient groups

A1

Active Comparator group

Treatment:

Drug: Atazanavir

A2

Active Comparator group

Treatment:

Drug: Atazanavir/Ritonavir

A3 I

Experimental group

Treatment:

Drug: Atazanavir/Ritonavir+Omeprazole

A3 II

Experimental group

Treatment:

Drug: Atazanavir/Ritonavir+Omeprazole

B1

Active Comparator group

Treatment:

Drug: Atazanavir

B2

Active Comparator group

Treatment:

Drug: Atazanavir/Ritonavir

B3 I

Experimental group

Treatment:

Drug: Atazanavir/Ritonavir+Omeprazole

B3 II

Experimental group

Treatment:

Drug: Atazanavir/Ritonavir+Omeprazole

Trial contacts and locations

1

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