NCT01964365

Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Rosuvastatin and Fenofibric Acid in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cresto 20mg	tablet, rosuvastatin 20mg
DRUG	Fenofibric acid 135mg	capsule, fenofibric acid 135mg
DRUG	Cresto 20mg, Fenofibric acid 135mg	rosuvastatin 20mg, Fenofibric acid 135mg

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-10-17
• Last updated: 2014-02-13

Locations

1 site across 1 country: South Korea