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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Cresto 20mg, Fenofibric acid 135mg; Drug: Cresto 20mg; Drug: Fenofibric acid 135mg

• Registration Number: NCT01964365
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin + Fenofibric acid	Cresto 20mg, Fenofibric acid 135mg	multiple dose of the combination of Rosuvastatin 20mg and Fenofibric acid 135mg
Rosuvastatin	Cresto 20mg	multiple dose of Rosuvastatin 20mg
Fenofibric acid	Fenofibric acid 135mg	multiple dose of Fenofibric acid 135mg

Primary Outcome Measures

Name	Time	Method
Cmax	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
AUCtau	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary Outcome Measures

Name	Time	Method
Cmin	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Tmax	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
CL/F	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
T1/2	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Metabolic Ratio	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Trial Locations

Locations (1)

Inje University College of Medicine Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of