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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

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

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: CJ-30061 Drug: Exforge® 5/160mg & Lipitor® 20mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : October 29, 2016
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1(RTR) 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

Experimental: Sequence 2(RRT) 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

Experimental: Sequence 3(TRR) 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




Primary Outcome Measures :
  1. Cmax of amlodipine [ Time Frame: Up to 72 hours ]
  2. Cmax of valsartan [ Time Frame: Up to 72 hours ]
  3. Cmax of atorvastatin [ Time Frame: Up to 72 hours ]
  4. AUCt of amlodipine [ Time Frame: Up to 72 hours ]
  5. AUCt of valsartan [ Time Frame: Up to 72 hours ]
  6. AUCt of atorvastatin [ Time Frame: Up to 72 hours ]

Secondary Outcome Measures :
  1. tmax of amlodipine [ Time Frame: Up to 72 hours ]
  2. tmax of valsartan [ Time Frame: Up to 72 hours ]
  3. tmax of atorvastatin [ Time Frame: Up to 72 hours ]
  4. t1/2 of atorvastatin [ Time Frame: Up to 72 hours ]
  5. t1/2 of amlodipine [ Time Frame: Up to 72 hours ]
  6. t1/2 of valsartan [ Time Frame: Up to 72 hours ]
  7. AUCinf of amlodipine [ Time Frame: Up to 72 hours ]
  8. AUCinf of valsartan [ Time Frame: Up to 72 hours ]
  9. AUCinf of atorvastatin [ Time Frame: Up to 72 hours ]
  10. AUCt of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  11. Cmax of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  12. tmax of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  13. t1/2 of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]
  14. AUCinf of 2-OH atorvastatin [ Time Frame: Up to 72 hours ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT03657472


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: JaeWook Ko, PhD Samsung Medical Center

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03657472     History of Changes
Other Study ID Numbers: CJ_EXA_103
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 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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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists