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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01964365

Enrollment

Registered

2013-10-17

Start date

2013-09-30

Completion date

2013-12-31

Last updated

2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGCresto 20mg

tablet, rosuvastatin 20mg

DRUGFenofibric acid 135mg

capsule, fenofibric acid 135mg

DRUGCresto 20mg, Fenofibric acid 135mg

rosuvastatin 20mg, Fenofibric acid 135mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
CL/F	Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Cmin	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
T1/2	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026