Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03657472

Enrollment

Registered

2018-09-05

Start date

2016-09-19

Completion date

2016-11-09

Last updated

2018-09-05

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers

Interventions

DRUGCJ-30061

Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)

DRUGExforge® 5/160mg & Lipitor® 20mg

Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male aged 19 to 55 years at the time of signing informed consent form. * Subject with BMI from 19kg/m\^2 to 27kg/m\^2 * Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion criteria

* Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease. * Subject who fall under the criteria below in laboratory test. * AST/ALT, total bilirubin, GGT, Uric acid \> UNL (upper normal limit) x 1.5 * CPK \> UNL x 2.5 * CrCL \< 60mL/min * Subject who fall under the criteria below in Blood Pressure test (siSBP \< 100mmHg/siSBP ≥ 150mmHg or siDBP \< 70mmHg/siDBP ≥ 100mmHg)

Design outcomes

Primary

Measure	Time frame
Cmax of amlodipine	Up to 72 hours
Cmax of valsartan	Up to 72 hours
Cmax of atorvastatin	Up to 72 hours
AUCt of amlodipine	Up to 72 hours
AUCt of valsartan	Up to 72 hours
AUCt of atorvastatin	Up to 72 hours

Secondary

Measure	Time frame
t1/2 of amlodipine	Up to 72 hours
t1/2 of valsartan	Up to 72 hours
AUCinf of amlodipine	Up to 72 hours
AUCinf of valsartan	Up to 72 hours
t1/2 of 2-OH atorvastatin	Up to 72 hours
AUCt of 2-OH atorvastatin	Up to 72 hours
Cmax of 2-OH atorvastatin	Up to 72 hours
tmax of 2-OH atorvastatin	Up to 72 hours
AUCinf of atorvastatin	Up to 72 hours
AUCinf of 2-OH atorvastatin	Up to 72 hours
tmax of amlodipine	Up to 72 hours
tmax of valsartan	Up to 72 hours
tmax of atorvastatin	Up to 72 hours
t1/2 of atorvastatin	Up to 72 hours

Countries

South Korea

Outcome results

None listed

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