Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

HK inno.N Corporation52 enrolled

Overview

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Male Subjects

Interventions

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

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

CJ-30060 10/160/20mgDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea