Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 4:07 AM
Study NCT ID:
NCT01057433
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2010-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Sponsor:
Kowa Research Institute, Inc.
Organization:
Study Overview
Official Title:
Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: