Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
|Healthy Volunteers||Drug: Pitavastatin (NK-104) Drug: Lopinavir/ritonavir||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers|
- Area Under the Curve From Time 0 to Tau (AUC 0-τ) [ Time Frame: 12 hours ]Area under the curve from start to elimination.
- Adverse Events [ Time Frame: 24 Days ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Healthy adult subjects
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Name: LivaloDrug: Lopinavir/ritonavir
lopinavir/ritonavir 800 mg/200 mg
Other Name: Kaletra
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057433
|United States, Texas|
|Austin, Texas, United States|
|Study Director:||Roger Morgan, MD, FACS||Kowa Research Institute, Inc.|