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CKD-337 Drug Interaction Study

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02066207
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
2.4
Actual Duration (Months)
12.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers
Actual Study Start Date :
Mar 18, 2014
Actual Primary Completion Date :
Apr 7, 2014
Actual Study Completion Date :
May 29, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fenofibrate

Subjects received Fenofibrate

Drug: Fenofibrate
Experimental: Atorvastatin

Subjects received Atorvastatin

Drug: Atorvastatin
Experimental: Fenofibrate and Atorvastatin

Subjects received Fenofibrate and Atorvastatin

Drug: Fenofibrate

Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Wooseong Huh, M.D., Ph.D., Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02066207
Other Study ID Numbers:
  • 146DDI13024
First Posted:
Feb 19, 2014
Last Update Posted:
Aug 8, 2017
Last Verified:
Mar 1, 2014
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyslipidemias
Atorvastatin
Fenofibrate

Study Results

No Results Posted as of Aug 8, 2017