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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-30039; Drug: fenofibric acid

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CJ-30039; Incrementally Modified Drugs of fenofibric acid	Drug: CJ-30039; single dose; Other Names: Incrementally Modified Drugs of fenofibric acid
ACTIVE_COMPARATOR: fenofibric acid; Greencross Lipidil Supra 160mg	Drug: fenofibric acid; single dose; Other Names: Greencross Lipidil Supra 160mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Min-su Park, MD PhD, Severance Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: December 24, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (ESTIMATE): December 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 29, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibric acid; Fenofibrate
• Other Study ID Numbers: CJ_FEN_101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO