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Completed

NCT Number: NCT03657472

Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CJ-30061

Drug

Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)

Exforge® 5/160mg & Lipitor® 20mg

Drug

Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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