Skip to main content
OpenTrials
Completed

NCT Number: NCT02066207

CKD-337 Drug Interaction Study

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

atorvastatin

Drug

Primary outcomes

  1. AUCt, Cmax,ss of fenofibric acid and atorvastatin

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Secondary outcomes

  1. Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.