CKD-337 Drug Interaction Study

Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02066207

Enrollment

Registered

2014-02-19

Start date

2014-03-18

Completion date

2014-05-29

Last updated

2017-08-08

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

Conditions

Dyslipidemia (Fredrickson Type Ⅱa), Dyslipidemia (Fredrickson Type Ⅱb)

Brief summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.

Interventions

DRUGFenofibrate

DRUGAtorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* A healthy male volunteer between 19 and 55 years old. * BMI between 18.5 and 27. * Able to participate in the entire trial * Signed the informed consent form prior to study participation.

Exclusion criteria

* Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system * sit SBP \< 100mmHg or sit SBP ≥ 150mmHg or sit DBP \< 70mmHg or sit DBP ≥ 100mmHg * Have acute infection history within 14 days * Have a allergic disease of need to treat * Have hypersensitivity reactions history for IP or any specific drugs. * AST, ALT or Total bilirubin \> UNL \* 1.5 * Estimated GFR \< 60 ml/min * Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * A heavy smoker (cigarette \> 10 cigarettes per day) * A heavy alcohol consumer (alcohol \> 140g/week) * A heavy grapefruit consumer (more than 1cup per a day) * Have a history of drug abuse or showed a positive for urine drug test. * Administrated IP within 60 days prior to screening * Rhabdomyolysis include of having a history or family history of genetic muscle diseases * Positive for HIV antibody, HBsAg, HCV antibody test * Previously donate whole blood within 60 days or component blood within 30 days * Subject takes ethical drug or herbal medicine within 30 days * Clinically significant laboratory test result * An impossible one who participates in clinical trial by investigator's decision including other reason

Design outcomes

Primary

Measure	Time frame
AUCt, Cmax,ss of fenofibric acid and atorvastatin	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Secondary

Measure	Time frame
Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Countries

South Korea

Outcome results

None listed

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