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Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

2014-08-27 03:16:21 | BioPortfolio

Summary

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Description

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Healthy Volunteers

Intervention

Pitavastatin, Lopinavir/ritonavir

Location

Austin
Texas
United States

Status

Active, not recruiting

Source

Kowa Research Institute, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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