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A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

Primary Purpose

Hypertension, Dyslipidemias

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-386 formulation 1
CKD-386 formulation 2
D326, D337 and D013
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring CKD-386, Pharmacokinetics, D326, D337, D013

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy volunteers aged between ≥20 and ≤45 years old
  2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
  3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
  5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

  1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
  2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Sites / Locations

  • Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)

Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)

Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)

Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013

Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)

Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)

Outcomes

Primary Outcome Measures

AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Cmax: Maximum plasma concentration of the drug

Secondary Outcome Measures

AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUCinf: Area under the concentration-time curve from zero up to ∞
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Tmax: Time to maximum plasma concentration
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
t1/2: Terminal elimination half-life
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
CL/F: Apparent total body clearance of the drug
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Vd/F: Apparent volume of distribution
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
AUC0-t: Area under the concentration-time curve from time zero to time
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Cmax: Maximum plasma concentration of the drug

Full Information

First Posted
April 8, 2019
Last Updated
April 17, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03920579
Brief Title
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
Official Title
A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

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
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
Detailed Description
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias
Keywords
CKD-386, Pharmacokinetics, D326, D337, D013

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)
Intervention Type
Drug
Intervention Name(s)
CKD-386 formulation 1
Other Intervention Name(s)
CKD-386 Test 1
Intervention Description
A single oral dose of 1 tablet under fasting conditions for each period
Intervention Type
Drug
Intervention Name(s)
CKD-386 formulation 2
Other Intervention Name(s)
CKD-386 Test 2
Intervention Description
A single oral dose of 1 tablet under fasting conditions for each period
Intervention Type
Drug
Intervention Name(s)
D326, D337 and D013
Other Intervention Name(s)
CKD-386 Reference
Intervention Description
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Primary Outcome Measure Information:
Title
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Description
AUC0-t: Area under the concentration-time curve from time zero to time
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Secondary Outcome Measure Information:
Title
AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
AUCinf: Area under the concentration-time curve from zero up to ∞
Time Frame
0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31
Title
Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
Tmax: Time to maximum plasma concentration
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
t1/2: Terminal elimination half-life
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
CL/F: Apparent total body clearance of the drug
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
Vd/F: Apparent volume of distribution
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
AUC0-t: Area under the concentration-time curve from time zero to time
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Title
Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

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: Healthy volunteers aged between ≥20 and ≤45 years old Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2 Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongseong Shin, M.D, Ph.D
Phone
+82-32-460-9459
Email
dsshin@gilhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongseong Shin, M.D, Ph.D
Organizational Affiliation
Clinical Trials Center, Gil Medical Center, Incheon, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongseong Shin, M.D, Ph.D
Phone
+82-32-460-9459
Email
dsshin@gilhospital.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

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