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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-30039; Drug: fenofibric acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01501435

CJ_FEN_101

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

CJ-30039

Experimental group

Description:

Incrementally Modified Drugs of fenofibric acid

Treatment:

Drug: CJ-30039

fenofibric acid

Active Comparator group

Description:

Greencross Lipidil Supra 160mg

Treatment:

Drug: fenofibric acid