NCT01057433

Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Pitavastatin (NK-104)	pitavastatin (NK-104) 4 mg once daily (QD)
DRUG	Lopinavir/ritonavir	lopinavir/ritonavir 800 mg/200 mg

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-01-27
• Last updated: 2021-06-22
• Results posted: 2012-08-13

Locations

1 site across 1 country: United States