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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Fenofibrate; Fenofibric acid; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years

2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result

3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.

2. A subject who shows the following result in clinical laboratory test

• AST, ALT > 1.25 times of the upper limit of normal range

• PR ≥ 210 msec

• QRS ≥ 120 msec

• QT ≥ 500 msec

• QTcF ≥ 500 msec

3. Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication