NCT02422030

CKD-337(2) Drug-drug Interaction Study

A Randomized, Open-label, Multiple Dosing, 3-way Crossover Study to Evaluate the Drug-drug Interaction Between Atorvastatin and Fenofibric Acid in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acid.

Detailed description

This study is a randomized, open-label, multiple dosing, 3-way crossover design to evaluate the drug-drug interaction between Atorvastatin (Lipitor) and Fenofibric (Trilipix) acid in healthy male subjects. Subjects will receive repeated dose of Atorvastatin (40mg\*1Tab/day) or Fenofibric acid (135mg\*1Cap/day) or Atorvastatin (40mg\*1Tab/day)/Fenofibric acid (135mg\*1Cap/day). Each treatment period was separated by a washout period of at least 8 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lipitor Tab. 40mg
DRUG	Trilipix 135mg

Timeline

• Start date: 2015-03-17
• Primary completion: 2015-03-22
• Completion: 2015-04-30
• First posted: 2015-04-21
• Last updated: 2017-08-08

Locations

1 site across 1 country: South Korea