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Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639493
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE April 6, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2018)
  • Cmax of amlodipine [ Time Frame: Up to 144 hours post-dose ]
  • Cmax of valsartan [ Time Frame: Up to 144 hours post-dose ]
  • Cmax of rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  • AUClast of amlodipine [ Time Frame: Up to 144 hours post-dose ]
  • AUClast of valsartan [ Time Frame: Up to 144 hours post-dose ]
  • AUClast of rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2018)
AUCinf of amlodipine, valsaran, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
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-30060 in Healthy Male Volunteers
Official Title  ICMJE An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects
Brief Summary To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
Detailed Description The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Subjects
Intervention  ICMJE
  • Drug: Exforge® tab 10/160mg, Crestor® tab 20mg
    Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
  • Drug: CJ-30060 10/160/20mg
    Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
Study Arms  ICMJE
  • Experimental: Sequence 1
    • Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg
    • Period 2: receive CJ-30060 10/160/20mg
    Interventions:
    • Drug: Exforge® tab 10/160mg, Crestor® tab 20mg
    • Drug: CJ-30060 10/160/20mg
  • Experimental: Sequence 2
    • Period 1: receive CJ-30060 10/160/20mg
    • Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg
    Interventions:
    • Drug: Exforge® tab 10/160mg, Crestor® tab 20mg
    • Drug: CJ-30060 10/160/20mg
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: August 19, 2018)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 17, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males aged 20 to 45 years at screening
  • BMI: 18 ~ 29.9kg/m^2
  • Body weight ≥ 50kg
  • Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

  • Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
  • Subjects who have symptoms of an acute disease within 28 days before first administration
  • Subjects who have clinically significant active, chronic disease
  • Subjects who fall under the criteria below in laboratory test

    • AST/ALT > UNL (upper normal limit) x 2
    • Total bilirubin > UNL x 1.5
    • CrCL < 50mL/min
    • CPK > UNL x 2.5
  • Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)
  • Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 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 NCT03639493
Other Study ID Numbers  ICMJE CJ_EXR_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: Ji Young Park, PhD Korea University Anam Hospital
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