Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01767610
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2013-01-11
Brief Title:
Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
Sponsor:
Hanlim Pharm Co Ltd
Organization:
Hanlim Pharm Co Ltd
Study Overview
Official Title:
Open-label Randomized Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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:
To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap 160mg and Livalo tab 2mg through 3 period by separately or combinedly
Detailed Description:
To develop combination product of micronized fenofibrate plus pitavastatin we would like to evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic characteristics of each arms after repeated administrating Lipilfen cap 160mgmicronized fenofibrate 160mgby Dae Woong Pharma and Livaro tab 2mg pitavastatin Ca 2mg by Joong Wae Pharm through 3 period by separately or combinedly
Study Oversight
Has Oversight DMC:
None
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?:
None