CKD-391 Pharmacokinetic Study Phase I

Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02501200

Enrollment

Registered

2015-07-17

Start date

2015-08-31

Completion date

2015-12-31

Last updated

2016-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Dyslipidemia, CKD-391, Atorvastatin, Ezetimibe

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.

Interventions

DRUGCKD-391

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

DRUGAtrovastatin and Ezetimibe combination therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUClast	up to 96 hours post dose
Cmax	up to 96 hours post dose

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026