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Compare the Pharmacokinetics and Safety of CKD-391

Primary Purpose

Hyperlipidemias

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CKD-391 10/10mg

D090, D337

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Between 19 aged and 45 aged in healthy male adult
Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
Not abnormal or not clinically significant lab values.
Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

No history or presence of clinically significant diseases.
Subjects showing adverse reaction to investigational product
Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
History of myopathy
unable to stop drinking and smoking during clinical trials
Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
History of drug abuse
Disagree to contraception
Subjects who are in any conditions impossible participating in the clinical trials

Sites / Locations

Jae-Yong Chung

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T

R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T

T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R

T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R

Outcomes

Primary Outcome Measures

Cmax

To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1) Atorvastatin, unconjugated ezetimibe(Cmax)

AUCt

To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1) Atorvastatin, unconjugated ezetimibe(AUCt)

Secondary Outcome Measures

Full Information

NCT ID

NCT04354987

First Posted

April 14, 2020

Last Updated

April 17, 2020

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04354987

Brief Title

Compare the Pharmacokinetics and Safety of CKD-391

Official Title

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 30, 2019 (Actual)

Primary Completion Date

January 9, 2020 (Actual)

Study Completion Date

January 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T

Arm Title

Group B

Arm Type

Experimental

Arm Description

R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T

Arm Title

Group C

Arm Type

Experimental

Arm Description

T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R

Arm Title

Group D

Arm Type

Experimental

Arm Description

T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R

Intervention Type

Drug

Intervention Name(s)

CKD-391 10/10mg

Other Intervention Name(s)

Test Drug (T)

Intervention Description

Drug T: CKD-391 10/10mg(Other Name: Test Drug)

Intervention Type

Drug

Intervention Name(s)

D090, D337

Other Intervention Name(s)

Reference Drug (R)

Intervention Description

D090 and D337 co-administration(Other Name: Reference drug)

Primary Outcome Measure Information:

Title

Cmax

Description

To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1) Atorvastatin, unconjugated ezetimibe(Cmax)

Time Frame

0~72hours

Title

AUCt

Description

To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1) Atorvastatin, unconjugated ezetimibe(AUCt)

Time Frame

0~72hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations. Not abnormal or not clinically significant lab values. Subjects who signed informed consent form with good understandings after explanations by investigators. Exclusion Criteria: No history or presence of clinically significant diseases. Subjects showing adverse reaction to investigational product Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. History of myopathy unable to stop drinking and smoking during clinical trials Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days History of drug abuse Disagree to contraception Subjects who are in any conditions impossible participating in the clinical trials

Facility Information:

Facility Name

Jae-Yong Chung

City

Gyeonggi-do

State/Province

Seongnam-si

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Compare the Pharmacokinetics and Safety of CKD-391

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