Bioequivalence Study of CJ-30060 in Healthy Volunteers

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03757390

Enrollment

Registered

2018-11-28

Start date

2018-11-09

Completion date

2018-12-14

Last updated

2018-11-28

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

Conditions

Healthy Subjects

Brief summary

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

Interventions

DRUGExforge® tab 5/160mg, Crestor® tab 10mg

co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg

DRUGCJ-30060 5/160/10mg

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers aged 20 to 45 years at screening * BMI: 18\ 29.9kg/㎡ * 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 28days 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) × 2 * Total bilirubin \> UNL × 1.5 * CrCL \< 50mL/min * CPK \> UNL × 2.5 * Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg) * Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests

Design outcomes

Primary

Measure	Time frame
AUClast of rosuvastatin	Up to 72 hours post-dose
AUClast of amlodipine	Up to 144 hours post-dose
AUClast of valsartan	Up to 48 hours post-dose
Cmax of rosuvastatin	Up to 72 hours post-dose
Cmax of amlodipine	Up to 144 hours post-dose
Cmax of valsartan	Up to 48 hours post-dose

Secondary

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

Countries

South Korea

Contacts

Primary ContactHyo-Sook Seo

hs.seo1@cj.net82-2-6477-0262

Backup ContactMin-ja Kang

minja.kang@cj.net82-2-6477-0260

Outcome results

None listed

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