Drug Interaction Study With Proton Pump Inhibitor
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
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/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: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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: June 16, 2008
|
