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Completed

NCT Number: NCT03009474

Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg 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® 5/160mg, Crestor 10mg 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 male aged 20 to 45 years at the screening
  • Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
  • Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion criteria

  • Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
  • Subject who have symptoms, result from acute disease within 28days before first administration.
  • Subject who have chronic persisting disease with clinical significance.
  • Subject who fall under the criteria below in laboratory test.
  • AST/ALT > UNL (upper normal limit) x 2
  • Total bilirubin > UNL x 1.5
  • In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
  • CPK > UNL x 2.5
  • Subject who with low blood pressure with clinical significance at screening test.

(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)

  • Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.

Treatment and study plan

CJ-30060

Drug

Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg

Exforge tab 5/160mg, Crestor tab 10mg

Drug

Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg

Primary outcomes

  1. Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

  2. Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

  3. Half life (t1/2) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

  4. Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

  5. Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin

    Time frame: Up to 144 hours post-dose

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2017
Registry last updated
Jan 4, 2017

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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