Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Healthy adult subjects

Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Lopinavir/ritonavir
Intervention descriptions: intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: lopinavir/ritonavir 800 mg/200 mg

Protocol document: