Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT01057433
Study type	Interventional
Source	Kowa Research Institute, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	January 2010
Completion date	December 2010

View Details

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