NCT02250976

The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca

A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Detailed description

To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Livasupril Cap.160/2mg	Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
DRUG	Lipilfen cap. 160mg	Micronized fenofibrate 160mg
DRUG	Livaro tab. 2mg	Pitavastatin Ca 2mg

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-09-26
• Last updated: 2018-08-03

Locations

1 site across 1 country: South Korea