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出境医 / 临床实验 / A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

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

Study Description
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
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Dongseong Shin, M.D, Ph.D Clinical Trials Center, Gil Medical Center, Incheon, Korea
Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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 ∞
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Dyslipidemias
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
  • 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)
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
  • 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)
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
  • 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
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
  • 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)
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
  • 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)
    Interventions:
    • Drug: CKD-386 formulation 1
    • Drug: CKD-386 formulation 2
    • Drug: D326, D337 and D013
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920579
Other Study ID Numbers  ICMJE 183PK18034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dongseong Shin, M.D, Ph.D Clinical Trials Center, Gil Medical Center, Incheon, Korea
PRS Account Chong Kun Dang Pharmaceutical
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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