Drug Interaction Study With Proton Pump Inhibitor

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357240

Enrollment

Registered

2006-07-27

Start date

2006-06-30

Completion date

2006-08-31

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Protease inhibitor

Brief 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.

Interventions

DRUGAtazanavir

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

DRUGAtazanavir/Ritonavir

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

DRUGAtazanavir/Ritonavir+Omeprazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.	—

Secondary

Measure	Time frame
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026