Bioequivalence Study of CJ-30060 in Healthy 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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2018-12-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

* period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
* period 2: receive CJ-30060 5/160/10mg

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

CJ-30060 5/160/10mg

Intervention Type DRUG

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

Sequence 2

* period 1: receive CJ-30060 5/160/10mg
* period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

CJ-30060 5/160/10mg

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

CJ-30060 5/160/10mg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes