CKD-391 Pharmacokinetic Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CKD-391; Drug: Atrovastatin and Ezetimibe combination therapy

• Registration Number: NCT02461004
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• Bwt >=50kg, BMI 18~29
• signed the informed consent form prior to the study participation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RT group	Atrovastatin and Ezetimibe combination therapy	combination dose of Atrovastatin and Ezetimibe and CKD-391 in order
TR group	CKD-391	CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
TR group	Atrovastatin and Ezetimibe combination therapy	CKD-391 and combination dose of Atrovastatin and Ezetimibe in order
RT group	CKD-391	combination dose of Atrovastatin and Ezetimibe and CKD-391 in order

Primary Outcome Measures

Name	Time	Method
AUClast	up to 96 hours post dose
Cmax	up to 96 hours post dose

Secondary Outcome Measures

Name	Time	Method
Tmax	up to 96 hours post dose
T1/2	up to 96 hours post dose
AUCinf	up to 96 hours post dose
Adverse events	up to 24days post dose

Trial Locations

Locations (1)

The Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of