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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cresto 20mg, Fenofibric acid 135mg; Drug: Fenofibric acid 135mg; Drug: Cresto 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964365

DW_DWJ1330001

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Rosuvastatin

Experimental group

Description:

multiple dose of Rosuvastatin 20mg

Treatment:

Drug: Cresto 20mg

Fenofibric acid

Experimental group

Description:

multiple dose of Fenofibric acid 135mg

Treatment:

Drug: Fenofibric acid 135mg

Rosuvastatin + Fenofibric acid

Experimental group

Description:

multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg

Treatment:

Drug: Cresto 20mg, Fenofibric acid 135mg