CKD-391 Pharmacokinetic Study Phase I

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Atrovastatin and Ezetimibe combination therapy; Drug: CKD-391

Study type: Interventional

Funder types: Industry

Identifiers

NCT02501200

152BE15026

Details and patient eligibility

About

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

Full description

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.

Enrollment: 46 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

TR group

Experimental group

Description:

CKD-391 and combination dose of Atrovastatin and Ezetimibe in order

Treatment:

Drug: Atrovastatin and Ezetimibe combination therapy

Drug: CKD-391

RT group

Experimental group

Description:

combination dose of Atrovastatin and Ezetimibe and CKD-391 in order

Treatment:

Drug: Atrovastatin and Ezetimibe combination therapy

Drug: CKD-391