Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

NCT ID: NCT03639493

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2018-05-17

Brief Summary

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

Detailed Description

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.

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

• Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg
• Period 2: receive CJ-30060 10/160/20mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

CJ-30060 10/160/20mg

Intervention Type: DRUG

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

Sequence 2

• Period 1: receive CJ-30060 10/160/20mg
• Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

CJ-30060 10/160/20mg

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

CJ-30060 10/160/20mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji Young Park, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CJ_EXR_103

Identifier Type: -

Identifier Source: org_study_id