CKD-391 Pharmacokinetic Study Phase I

Chong Kun Dang Pharmaceutical46 enrolled

Overview

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial. Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CKD-391DRUG

Investigational product is prescribed to all of randomized subjects for two times.

Atrovastatin and Ezetimibe combination therapyDRUG

Investigational products are prescribed to all of radomized subjects for two times.

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Bwt \>=50kg, BMI 18.5\~25 * signed the informed consent form prior to the study participation Exclusion Criteria: * \- Clinically significant disease * Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug * Clinically significant allergic disease * Impossible to taking the institutional standard meal * Previously donate whole blood within 60 days or component blood within 20 days * Previously participated in other trial within 90 days * Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials * An impossible one who participates in clinical trial by investigator's decision including laboratory test result