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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

multiple dose of Rosuvastatin 20mg

Group Type EXPERIMENTAL

Cresto 20mg

Intervention Type DRUG

tablet, rosuvastatin 20mg

Fenofibric acid

multiple dose of Fenofibric acid 135mg

Group Type EXPERIMENTAL

Fenofibric acid 135mg

Intervention Type DRUG

capsule, fenofibric acid 135mg

Rosuvastatin + Fenofibric acid

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

Group Type EXPERIMENTAL

Cresto 20mg, Fenofibric acid 135mg

Intervention Type DRUG

rosuvastatin 20mg, Fenofibric acid 135mg

Interventions

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Cresto 20mg

tablet, rosuvastatin 20mg

Intervention Type DRUG

Fenofibric acid 135mg

capsule, fenofibric acid 135mg

Intervention Type DRUG

Cresto 20mg, Fenofibric acid 135mg

rosuvastatin 20mg, Fenofibric acid 135mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes