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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: CJ-30060; Drug: Exforge tab 5/160mg, Crestor tab 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03009474

CJ_EXR_102

Details and patient eligibility

About

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Full description

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.

Enrollment: 52 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

CJ-30060

Experimental group

Description:

Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg

Treatment:

Drug: Exforge tab 5/160mg, Crestor tab 10mg

Exforge tab 5/160mg, Crestor tab 10mg

Active Comparator group

Description:

Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg

Treatment:

Drug: CJ-30060