Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
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|ClinicalTrials.gov Identifier: NCT01057433|
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : August 13, 2012
Last Update Posted : June 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Pitavastatin (NK-104) Drug: Lopinavir/ritonavir||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Healthy adult subjects
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Name: Livalo
lopinavir/ritonavir 800 mg/200 mg
Other Name: Kaletra
- Area Under the Curve From Time 0 to Tau (AUC 0-τ) [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24 ]Area under the curve from start to elimination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057433
|United States, Texas|
|Austin, Texas, United States|
|Study Director:||Roger Morgan, MD, FACS||Kowa Research Institute, Inc.|