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Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT03657472
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE September 19, 2016
Actual Primary Completion Date October 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2018)
  • Cmax of amlodipine [ Time Frame: Up to 72 hours ]
  • Cmax of valsartan [ Time Frame: Up to 72 hours ]
  • Cmax of atorvastatin [ Time Frame: Up to 72 hours ]
  • AUCt of amlodipine [ Time Frame: Up to 72 hours ]
  • AUCt of valsartan [ Time Frame: Up to 72 hours ]
  • AUCt of atorvastatin [ Time Frame: Up to 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2018)
  • tmax of amlodipine [ Time Frame: Up to 72 hours ]
  • tmax of valsartan [ Time Frame: Up to 72 hours ]
  • tmax of atorvastatin [ Time Frame: Up to 72 hours ]
  • t1/2 of atorvastatin [ Time Frame: Up to 72 hours ]
  • t1/2 of amlodipine [ Time Frame: Up to 72 hours ]
  • t1/2 of valsartan [ Time Frame: Up to 72 hours ]
  • AUCinf of amlodipine [ Time Frame: Up to 72 hours ]
  • AUCinf of valsartan [ Time Frame: Up to 72 hours ]
  • AUCinf of atorvastatin [ Time Frame: Up to 72 hours ]
  • AUCt of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  • Cmax of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  • tmax of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  • t1/2 of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  • AUCinf of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of CJ-30061 in Healthy Male Volunteers
Official Title  ICMJE An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers
Brief Summary To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hypertension
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: CJ-30061
    Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
  • Drug: Exforge® 5/160mg & Lipitor® 20mg
    Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
Study Arms  ICMJE
  • Experimental: Sequence 1(RTR)
    Interventions:
    • Drug: CJ-30061
    • Drug: Exforge® 5/160mg & Lipitor® 20mg
  • Experimental: Sequence 2(RRT)
    Interventions:
    • Drug: CJ-30061
    • Drug: Exforge® 5/160mg & Lipitor® 20mg
  • Experimental: Sequence 3(TRR)
    Interventions:
    • Drug: CJ-30061
    • Drug: Exforge® 5/160mg & Lipitor® 20mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2018)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 9, 2016
Actual Primary Completion Date October 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male aged 19 to 55 years at the time of signing informed consent form.
  • Subject with BMI from 19kg/m^2 to 27kg/m^2
  • Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion Criteria:

  • Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
  • Subject who fall under the criteria below in laboratory test.

    • AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
    • CPK > UNL x 2.5
    • CrCL < 60mL/min
  • Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657472
Other Study ID Numbers  ICMJE CJ_EXA_103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CJ HealthCare Corporation
Study Sponsor  ICMJE CJ HealthCare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JaeWook Ko, PhD Samsung Medical Center
PRS Account CJ HealthCare Corporation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP