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Drug Interaction Study With Proton Pump Inhibitor

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir (Drug); Atazanavir/Ritonavir (Drug); Atazanavir/Ritonavir+Omeprazole (Drug); Atazanavir/Ritonavir+Omeprazole (Drug); Atazanavir (Drug); Atazanavir/Ritonavir (Drug); Atazanavir/Ritonavir+Omeprazole (Drug); Atazanavir/Ritonavir+Omeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.

Secondary outcome: PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18

to 32 kg/m2

Locations and Contacts

Local Institution, Hamilton, New Jersey, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2006
Last updated: April 7, 2011

Page last updated: August 23, 2015

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