Status:
COMPLETED
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01501435
Start Date
December 1 2011
End Date
June 1 2012
Last Update
January 2 2017
Active Locations (1)
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1
Yonsei university severance hospital
Seoul, South Korea