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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920579
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: CKD-386 formulation 1 Drug: CKD-386 formulation 2 Drug: D326, D337 and D013 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
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)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference

Experimental: Sequence 2
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)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference

Experimental: Sequence 3
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)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference

Experimental: Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference

Experimental: Sequence 5
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)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference

Experimental: Sequence 6
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)
Drug: CKD-386 formulation 1
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 1

Drug: CKD-386 formulation 2
A single oral dose of 1 tablet under fasting conditions for each period
Other Name: CKD-386 Test 2

Drug: D326, D337 and D013
A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
Other Name: CKD-386 Reference




Primary Outcome Measures :
  1. AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    AUC0-t: Area under the concentration-time curve from time zero to time

  2. Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    Cmax: Maximum plasma concentration of the drug


Secondary Outcome Measures :
  1. 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 [ Time Frame: 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31 ]
    AUCinf: Area under the concentration-time curve from zero up to ∞

  2. 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 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    Tmax: Time to maximum plasma concentration

  3. 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 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    t1/2: Terminal elimination half-life

  4. CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    CL/F: Apparent total body clearance of the drug

  5. Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    Vd/F: Apparent volume of distribution

  6. AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    AUC0-t: Area under the concentration-time curve from time zero to time

  7. Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013 [ Time Frame: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31 ]
    Cmax: Maximum plasma concentration of the drug



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920579


Contacts
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Contact: Dongseong Shin, M.D, Ph.D +82-32-460-9459 dsshin@gilhospital.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Contact: Dongseong Shin, M.D, Ph.D    +82-32-460-9459    dsshin@gilhospital.com   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Dongseong Shin, M.D, Ph.D Clinical Trials Center, Gil Medical Center, Incheon, Korea
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03920579    
Other Study ID Numbers: 183PK18034
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-386
Pharmacokinetics
D326
D337
D013
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases