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出境医 / 临床实验 / Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

Study Description
Brief Summary:
This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T Phase 1

Detailed Description:

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab.

Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
Actual Study Start Date : July 28, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : September 4, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1
  1. Period 1: Treatment A
  2. Period 2: Treatment B
  3. Period 3: Treatment C
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Experimental: Group 2
  1. Period 1: Treatment C
  2. Period 2: Treatment A
  3. Period 3: Treatment B
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Experimental: Group 3
  1. Period 1: Treatment B
  2. Period 2: Treatment C
  3. Period 3: Treatment A
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Experimental: Group 4
  1. Period 1: Treatment C
  2. Period 2: Treatment B
  3. Period 3: Treatment A
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Experimental: Group 5
  1. Period 1: Treatment B
  2. Period 2: Treatment A
  3. Period 3: Treatment C
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Experimental: Group 6
  1. Period 1: Treatment A
  2. Period 2: Treatment C
  3. Period 3: Treatment B
 Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment A

Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment B

Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
single oral administration under fasting condition
Other Name: Treatment C
Outcome Measures
Primary Outcome Measures :
  1. AUCt of CKD-330, D086, CKD-333 [ Time Frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours ]
    Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final

  2. Cmax of CKD-330, D086, CKD-333 [ Time Frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours ]
    The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 19 to 55 years old healthy subject at the screening

  2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg

    * BMI = Weight(kg)/ Height(m)2

  3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  4. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
  5. Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
  6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
  7. Individuals with the ability and willingness to participate during the study period

Exclusion Criteria:

  1. Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
  2. Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption

  3. Individuals with the following laboratory test results:

    • ALT or AST > 2x the upper limit of the normal range
    • CK > 3x the upper limit of the normal range
  4. A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
  5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
  6. Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
  7. Individuals with the following vital signs results at screening Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)
  8. Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
  9. Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
  10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
  11. Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
  12. Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
  13. Individuals with hypersensitivity to ingredients used in the investigational product(s)
  14. Patient with hyperkalemia
  15. Patients with hepatopathy
  16. Patients with hereditary angioedema, ACE inhibitors or angiotensin Ⅱ receptor antagonists who have a history of angioedema
  17. Primary hyperaldosteronism
  18. Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
  19. Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
  20. Patients with Intravascular volume depletion
  21. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
  22. Patients with renal artery stenosis
  23. Patients with muscle disease
  24. Patients with Hypothyroidism
  25. Women who are pregnant or may be pregnant
  26. Patients with a history of muscle toxicity when using statins or fibrates
  27. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  28. Individuals who were deemed to be inappropriate to participate in the study by the investigator
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Chonbuk National University Hospital
Jeonju, South Korea, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE July 28, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • AUCt of CKD-330, D086, CKD-333 [ Time Frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours ]
    Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final
  • Cmax of CKD-330, D086, CKD-333 [ Time Frame: Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours ]
    The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
Official Title  ICMJE A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers
Brief Summary This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.
Detailed Description

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: 1) CKD-330 16/10mg Tab. 2) D086 Tab. Test drug: 1) CKD-333 16/10/40mg formulation 1 Tab. 2) CKD-333 16/10/40mg formulation 2 Tab.

Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
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-330 16/10mg Tab. 1T and D086 Tab. 1T
    single oral administration under fasting condition
    Other Name: Treatment A
  • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    single oral administration under fasting condition
    Other Name: Treatment B
  • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
    single oral administration under fasting condition
    Other Name: Treatment C
Study Arms  ICMJE
  • Experimental: Group 1
    1. Period 1: Treatment A
    2. Period 2: Treatment B
    3. Period 3: Treatment C
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
  • Experimental: Group 2
    1. Period 1: Treatment C
    2. Period 2: Treatment A
    3. Period 3: Treatment B
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
  • Experimental: Group 3
    1. Period 1: Treatment B
    2. Period 2: Treatment C
    3. Period 3: Treatment A
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
  • Experimental: Group 4
    1. Period 1: Treatment C
    2. Period 2: Treatment B
    3. Period 3: Treatment A
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
  • Experimental: Group 5
    1. Period 1: Treatment B
    2. Period 2: Treatment A
    3. Period 3: Treatment C
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
  • Experimental: Group 6
    1. Period 1: Treatment A
    2. Period 2: Treatment C
    3. Period 3: Treatment B
    Interventions:
    • Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T
    • Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 4, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 19 to 55 years old healthy subject at the screening

  2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg

    * BMI = Weight(kg)/ Height(m)2

  3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  4. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
  5. Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
  6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
  7. Individuals with the ability and willingness to participate during the study period

Exclusion Criteria:

  1. Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
  2. Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption

  3. Individuals with the following laboratory test results:

    • ALT or AST > 2x the upper limit of the normal range
    • CK > 3x the upper limit of the normal range
  4. A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
  5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
  6. Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
  7. Individuals with the following vital signs results at screening Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)
  8. Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
  9. Individuals who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
  10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
  11. Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
  12. Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
  13. Individuals with hypersensitivity to ingredients used in the investigational product(s)
  14. Patient with hyperkalemia
  15. Patients with hepatopathy
  16. Patients with hereditary angioedema, ACE inhibitors or angiotensin Ⅱ receptor antagonists who have a history of angioedema
  17. Primary hyperaldosteronism
  18. Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
  19. Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
  20. Patients with Intravascular volume depletion
  21. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
  22. Patients with renal artery stenosis
  23. Patients with muscle disease
  24. Patients with Hypothyroidism
  25. Women who are pregnant or may be pregnant
  26. Patients with a history of muscle toxicity when using statins or fibrates
  27. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  28. Individuals who were deemed to be inappropriate to participate in the study by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 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 NCT04019743
Other Study ID Numbers  ICMJE A70_07BE1906P
Has Data Monitoring Committee Not Provided
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 Not Provided
PRS Account Chong Kun Dang Pharmaceutical
Verification Date January 2020

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

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