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OpenTrials
Completed

NCT Number: NCT03639493

Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

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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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Exforge® tab 10/160mg, Crestor® tab 20mg

Drug

Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg

CJ-30060 10/160/20mg

Drug

Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg

Primary outcomes

  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 outcomes

  1. AUCinf of amlodipine, valsaran, rosuvastatin

    Time frame: Up to 144 hours post-dose

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Aug 21, 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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