Bioequivalence Study of CJ-30060 in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03639493

Enrollment

Registered

2018-08-21

Start date

2018-04-06

Completion date

2018-05-17

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

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.

Interventions

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

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

DRUGCJ-30060 10/160/20mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax of valsartan	Up to 144 hours post-dose
AUClast of rosuvastatin	Up to 144 hours post-dose
Cmax of amlodipine	Up to 144 hours post-dose
AUClast of valsartan	Up to 144 hours post-dose
Cmax of rosuvastatin	Up to 144 hours post-dose
AUClast of amlodipine	Up to 144 hours post-dose

Secondary

Measure	Time frame
AUCinf of amlodipine, valsaran, rosuvastatin	Up to 144 hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026