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Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
T
R
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Between 19 aged and 45 aged in healthy male adult
  2. Over 50 kg, BMI between 18.0-29.0 kg/m2
  3. 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.
  4. Not abnormal or not clinically significant lab values.
  5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

  1. No history or presence of clinically significant diseases.
  2. Subjects showing adverse reaction to investigational product
  3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
  4. History of myopathy
  5. Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2
  6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
  7. Smoke over 10 cigarettes per day or unable to stop smoking
  8. Subjects who previously participated in other clinical trials within 90 days
  9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
  10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
  11. Taking medications which induce or block medication metabolism
  12. History of drug abuse
  13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
  14. Disagree to contraception
  15. Subjects who are in any conditions impossible participating in the clinical trials

Sites / Locations

  • INHA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A (R+T+R+T)

B (T+R+T+R)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cmax
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
AUCt
To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt

Secondary Outcome Measures

Full Information

First Posted
December 13, 2018
Last Updated
January 4, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03793985
Brief Title
Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
Official Title
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination

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
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A (R+T+R+T)
Arm Type
Experimental
Arm Description
Period 1 : R Period 2 : T Period 3 : R Period 4 : T
Arm Title
B (T+R+T+R)
Arm Type
Active Comparator
Arm Description
Period 1 : T Period 2 : R Period 3 : T Period 4 : R
Intervention Type
Drug
Intervention Name(s)
T
Other Intervention Name(s)
Test Drug
Intervention Description
CKD-391 40/10mg
Intervention Type
Drug
Intervention Name(s)
R
Other Intervention Name(s)
Reference drug
Intervention Description
D086 and D337 co-administration
Primary Outcome Measure Information:
Title
Cmax
Description
To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
Time Frame
0~72hours
Title
AUCt
Description
To evaluate pharmacokinetic equivalence of experimental arm comparing 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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Over 50 kg, BMI between 18.0-29.0 kg/m2 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 Subjects with abnormal lab values at least one below 1) AST or ALT>2 fold of upper normal limit 2) Total bilirubin>2 fold of upper normal limit 3) CK>2 fold of upper normal limit 4) Estimated Glomerular filtration rate<60mL/min/1.73m2 Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials Smoke over 10 cigarettes per day or unable to stop smoking Subjects who previously participated in other clinical trials within 90 days Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days. Taking medications which induce or block medication metabolism History of drug abuse Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days. Disagree to contraception Subjects who are in any conditions impossible participating in the clinical trials
Facility Information:
Facility Name
INHA University Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

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