Clinical trial NCT01501435: To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
Official title: A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-29
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of fenofibric acid
timeFrame: up to 48 hours
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of fenofibric acid
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university severance hospital
Study officials:
affiliation: Severance Hospital
name: Min-su Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: