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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01501435

Enrollment

Registered

2011-12-29

Start date

2011-12-31

Completion date

2012-06-30

Last updated

2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Pharmacokinetics

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.

Interventions

DRUGCJ-30039

single dose

DRUGfenofibric acid

single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax) of fenofibric acid	up to 48 hours

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026