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

NCT01501435 | Completed Phase 1

• 1 other identifier: CJ_FEN_101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of fenofibric acid

  up to 48 hours

Secondary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of fenofibric acid

  up to 48 hours

Study Arms (2)

CJ-30039

EXPERIMENTAL

Incrementally Modified Drugs of fenofibric acid

Drug: CJ-30039

fenofibric acid

ACTIVE COMPARATOR

Greencross Lipidil Supra 160mg

Drug: fenofibric acid

Interventions

CJ-30039 DRUG

single dose

Also known as: Incrementally Modified Drugs of fenofibric acid

CJ-30039

fenofibric acid DRUG

single dose

Also known as: Greencross Lipidil Supra 160mg

fenofibric acid

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Yonsei university severance hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

fenofibric acid

Study Officials

• Min-su Park, MD PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)