NCT01767610

Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin

Open-label, Randomized, Repeated Dosing Crossover Study to Evaluate the Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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. 160mg(micronized fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm. through 3 period by separately or combinedly.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	micronized fenofibrate 160mg
DRUG	pitavastatin Ca 2mg
DRUG	micronized fenofibrate 160mg plus pitavastatin Ca 2mg

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2013-01-14
• Last updated: 2018-08-03

Locations

1 site across 1 country: South Korea