To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ-30039; Drug: fenofibric acid

• Registration Number: NCT01501435
• Lead Sponsor: HK inno.N Corporation

Brief Summary

To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

Detailed Description

Study objectives

* To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.

* To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-24
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Male volunteers in the age between 20 and 55 years old
• BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
• Subject with no history of any significant chronic disease

Exclusion Criteria

• History of clinically significant allergies, including fenofibric acid or Fenofibrate

• History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease

• History of surgery except or gastrointestinal disease which might significantly change absorption of medicines

• Clinical laboratory test values are outside the accepted normal range

  • AST(ASpartate Transaminase), ALT(ALanine Transaminase)( > 1.25 times to normal range
  • Total bilirubin > 1.5 times to normal range
  • BUN(Blood Urea Nitrogen) > 25 mg/dL or Creatinine > 1.4 mg/dL
  • CK(Creatine Kinase) > 1.25 times to normal range

• Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2

• Clinically significant vital sign

  • SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
  • DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg

• History of drug abuse or positive urine screen for drugs

• History of caffeine, alcohol, smoking abuse

  • caffeine > 5 cups/day
  • alcohol > 201g/week
  • smoking > 10 cigarettes/day

• Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing

• Participated in a previous clinical trial within 60 days prior to dosing

• Donated blood within 60 days prior to dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CJ-30039	CJ-30039	Incrementally Modified Drugs of fenofibric acid
fenofibric acid	fenofibric acid	Greencross Lipidil Supra 160mg

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of fenofibric acid	up to 48 hours

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of fenofibric acid	up to 48 hours

Trial Locations

Locations (1)

Yonsei university severance hospital; 🇰🇷 Seoul, Korea, Republic of