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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

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.

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: Exforge® tab 10/160mg, Crestor® tab 20mg Drug: CJ-30060 10/160/20mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
  • Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg
  • Period 2: receive CJ-30060 10/160/20mg
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

Experimental: Sequence 2
  • Period 1: receive CJ-30060 10/160/20mg
  • Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg
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




Primary Outcome Measures :
  1. Cmax of amlodipine [ Time Frame: Up to 144 hours post-dose ]
  2. Cmax of valsartan [ Time Frame: Up to 144 hours post-dose ]
  3. Cmax of rosuvastatin [ Time Frame: Up to 144 hours post-dose ]
  4. AUClast of amlodipine [ Time Frame: Up to 144 hours post-dose ]
  5. AUClast of valsartan [ Time Frame: Up to 144 hours post-dose ]
  6. AUClast of rosuvastatin [ Time Frame: Up to 144 hours post-dose ]

Secondary Outcome Measures :
  1. AUCinf of amlodipine, valsaran, rosuvastatin [ Time Frame: Up to 144 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639493


Locations
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Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Ji Young Park, PhD Korea University Anam Hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03639493    
Other Study ID Numbers: CJ_EXR_103
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amlodipine, Valsartan Drug Combination
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents