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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00357240 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Atazanavir/Ritonavir Drug: Atazanavir/Ritonavir+Omeprazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
| 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 |
| Estimated Enrollment: | 56 |
| Study Start Date: | June 2006 |
| Arms | Assigned Interventions |
|---|---|
| A1: Active Comparator |
Drug: Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
|
| A2: Active Comparator |
Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
|
| A3 I: Experimental |
Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
|
| A3 II: Experimental |
Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
|
| B1: Active Comparator |
Drug: Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
|
| B2: Active Comparator |
Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
|
| B3 I: Experimental |
Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
|
| B3 II: Experimental |
Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | AI424-288 |
| Study First Received: | July 25, 2006 |
| Last Updated: | June 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00357240 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Protease inhibitor |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Omeprazole Infection Anti-Retroviral Agents Proton Pump Inhibitors Therapeutic Uses Anti-Ulcer Agents Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Gastrointestinal Agents Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |