Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2016-11-09

Brief Summary

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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

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Detailed Description

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1(RTR)

Group Type EXPERIMENTAL

CJ-30061

Intervention Type DRUG

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

Exforge® 5/160mg & Lipitor® 20mg

Intervention Type DRUG

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

Sequence 2(RRT)

Group Type EXPERIMENTAL

CJ-30061

Intervention Type DRUG

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

Exforge® 5/160mg & Lipitor® 20mg

Intervention Type DRUG

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

Sequence 3(TRR)

Group Type EXPERIMENTAL

CJ-30061

Intervention Type DRUG

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

Exforge® 5/160mg & Lipitor® 20mg

Intervention Type DRUG

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

Interventions

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CJ-30061

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

Intervention Type DRUG

Exforge® 5/160mg & Lipitor® 20mg

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes