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Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults (CKD-341)

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CKD-341, D958
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers, aged ≥ 19 years old at the time of screening Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 30.0 kg/m2 at the time of screening Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination According to the characteristics of the drug and Individuals who were deemed to be eligible based on the screening tests such as Clinical laboratory tests, vital signs, Physical examination, 12-lead electrocardiogram Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed Exclusion Criteria: Those with clinically significant diseases or history in liver, renal, neurological, psychiatric, respiratory, endocrine, tumor, urinary, cardiovascular, gastrointestinal, musculoskeletal system, etc or evidence one who has 1-1. Patients with biliary atresia and Severely liver dysfunction 1-2. Renal dysfunction 1-3. Shock patient 1-4. Patients with hypokalemia, hyponatremia and hypercalcemia 1-5. Addison's syndrome 1-6. Primary aldosteronism 1-7. Arterial valve/Mitral stenose or hypertrophic obstructive cardiomyopathy 1-8. Renovascular hypertension or anuria 1-9. Hypotension 1-10. Arteriosclerosis or cerebral arteriosclerosis 1-11. Patients with symptomatic hyperuricemia (history of gout or urolithiasis) or Patients with diabetes including family history 1-12. Hyperparathyroidism 1-13. Sympathectomy For female, pregnant female (Urine-human chorionic gonadotropin-positive) or lactating female Patients with hypersensitivity or a history of hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs Patients receiving lithium therapy Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery(crohn's disease, ulcer, acute/chronic pancreatitis) except simple appendectomy and hernia surgery(excluding appendicitis or hernia) which can interfere with drug absorption. Subjects with clinically significant findings including the following findings on 12-lead electrocardiogram at the time of screening corrected QT interval(QTc) > 450 ms for males, QTc > 470 ms for females Pulmonary Regurgitation(PR) interval > 200 ms QRS(QRS-complex) duration > 120 ms Subjects who shows the following results in a clinical laboratory test at the time of screening Aspartate aminotransferase (AST), Alanine aminotransferase(ALT), Alkaline phosphatase(ALP), γ-glutamyl transpeptidase(γ-GT) and Bilirubin total > 2 times higher than upper normal level Epidermal Growth Factor Receptor(eGFR) (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2 Creatine phosphokinase(CPK) > 2.5 times higher than upper normal level Those who has a drug abuse history within one year or positive reaction on urine drug screening test Under 5 min resting condition, systolic blood pressure >150 mmHg or or ≤ 90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg, pulse ≥100 bpm or ≤ 40 bpm Those who have administered drug metabolizing enzyme inducing or inhibiting drugs such as barbiturates within 1 month before the first administration date Those who eat abnormal diets that may affect the absorption, distribution, metabolism, and excretion of investigational drugs, or those who consume foods that may affect drug metabolism Cyclosporine, non-steroidal anti-inflammatory drugs, terfenadine, astemizole, digitalis, glucocorticosteroids, adrenocorticotropic hormone, and drugs affecting the renin-angiotensin-aldosterone system (RAAS) should be avoided within 2 weeks prior to the first dose. If you have administered any prescription drugs or herbal preparations that may affect the characteristics of clinical trial drugs, including a person who has administered any over-the-counter drug (OTC) or vitamin preparation within 10 days (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, the investigator may participate in the clinical trial at the discretion of the investigator.) Those who participated in other clinical trials within 6 months prior to the first administration date and received administration (However, the criteria for termination of participation in other clinical trials is based on the last administration date and the next day is counted as 1 day.) Whole blood donation or component blood donation within 1 month before the first administration date, blood transfusion within 1 month, or those who cannot avoid blood donation from the time of written consent of the subject to the time of Post-visit study Those who have continuously consumed alcohol (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the first administration date or cannot abstain from drinking from the time of consent of the subject to the time of Post-visit study Smokers whose average smoking amount exceeds 10 cigarettes per day within 3 months prior to the first administration date and those who cannot quit smoking from 24 hours prior to administration in each period to the time of the last blood collection Those who have consumed food containing grapefruit (grapefruit) from 48 hours before the first administration to the time of Post-visit study or who cannot refrain from eating Those who consumed caffeine-containing foods (coffee, green tea, black tea, carbonated beverages, coffee milk, nutritional tonic drinks, etc.) from 24 hours before administration to the last blood sampling, or who could not refrain from taking them. During the period from 48 hours before the first administration to the time of Post-visit study, those who have performed strenuous exercise that exceeds the level of daily life or who cannot refrain from strenuous exercise From the time of consent of the subject until 2 weeks after the date of the last clinical drug administration, reliable methods of contraception (e.g., contraceptive administration and implantation or intrauterine device, sterilization procedure (vasectomy) A person who is not using an excision, tubal ligation, etc.) or blocking method (combined use of spermicide with condom, vaginal diaphragm for contraception, vaginal sponge, or cervical cap) Those who are judged by the principal investigator for reasons other than the above selection/exclusion criteria and are judged unsuitable for participation in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sequence A

    Sequence B

    Arm Description

    Period 1: D958 Period 2: CKD-341 Period 3: D958 Period 4: CKD-341

    Period 1: CKD-341 Period 2: D958 Period 3: CKD-341 Period 4: D958

    Outcomes

    Primary Outcome Measures

    area under curve(AUC) of CKD-341, D958
    Area under the CKD-341, D958 concentration in blood-time curve from zero to final
    Cmax of CKD-341, D958
    The maximum CKD-341, D958 concentration in blood sampling time

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2023
    Last Updated
    June 18, 2023
    Sponsor
    Chong Kun Dang Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05921435
    Brief Title
    Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults
    Acronym
    CKD-341
    Official Title
    A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of D958 and CKD-341 in Healthy Adult Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 19, 2023 (Anticipated)
    Primary Completion Date
    July 18, 2023 (Anticipated)
    Study Completion Date
    September 9, 2023 (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 clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-341
    Detailed Description
    A Randomized, Open-label, Oral, Single-dose, 2-treatment, Replicate crossover, 4-period Stuy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence A
    Arm Type
    Experimental
    Arm Description
    Period 1: D958 Period 2: CKD-341 Period 3: D958 Period 4: CKD-341
    Arm Title
    Sequence B
    Arm Type
    Experimental
    Arm Description
    Period 1: CKD-341 Period 2: D958 Period 3: CKD-341 Period 4: D958
    Intervention Type
    Drug
    Intervention Name(s)
    CKD-341, D958
    Intervention Description
    A single dose of 1tablet under fasting condition
    Primary Outcome Measure Information:
    Title
    area under curve(AUC) of CKD-341, D958
    Description
    Area under the CKD-341, D958 concentration in blood-time curve from zero to final
    Time Frame
    Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours
    Title
    Cmax of CKD-341, D958
    Description
    The maximum CKD-341, D958 concentration in blood sampling time
    Time Frame
    Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers, aged ≥ 19 years old at the time of screening Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 30.0 kg/m2 at the time of screening Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination According to the characteristics of the drug and Individuals who were deemed to be eligible based on the screening tests such as Clinical laboratory tests, vital signs, Physical examination, 12-lead electrocardiogram Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed Exclusion Criteria: Those with clinically significant diseases or history in liver, renal, neurological, psychiatric, respiratory, endocrine, tumor, urinary, cardiovascular, gastrointestinal, musculoskeletal system, etc or evidence one who has 1-1. Patients with biliary atresia and Severely liver dysfunction 1-2. Renal dysfunction 1-3. Shock patient 1-4. Patients with hypokalemia, hyponatremia and hypercalcemia 1-5. Addison's syndrome 1-6. Primary aldosteronism 1-7. Arterial valve/Mitral stenose or hypertrophic obstructive cardiomyopathy 1-8. Renovascular hypertension or anuria 1-9. Hypotension 1-10. Arteriosclerosis or cerebral arteriosclerosis 1-11. Patients with symptomatic hyperuricemia (history of gout or urolithiasis) or Patients with diabetes including family history 1-12. Hyperparathyroidism 1-13. Sympathectomy For female, pregnant female (Urine-human chorionic gonadotropin-positive) or lactating female Patients with hypersensitivity or a history of hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs Patients receiving lithium therapy Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery(crohn's disease, ulcer, acute/chronic pancreatitis) except simple appendectomy and hernia surgery(excluding appendicitis or hernia) which can interfere with drug absorption. Subjects with clinically significant findings including the following findings on 12-lead electrocardiogram at the time of screening corrected QT interval(QTc) > 450 ms for males, QTc > 470 ms for females Pulmonary Regurgitation(PR) interval > 200 ms QRS(QRS-complex) duration > 120 ms Subjects who shows the following results in a clinical laboratory test at the time of screening Aspartate aminotransferase (AST), Alanine aminotransferase(ALT), Alkaline phosphatase(ALP), γ-glutamyl transpeptidase(γ-GT) and Bilirubin total > 2 times higher than upper normal level Epidermal Growth Factor Receptor(eGFR) (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2 Creatine phosphokinase(CPK) > 2.5 times higher than upper normal level Those who has a drug abuse history within one year or positive reaction on urine drug screening test Under 5 min resting condition, systolic blood pressure >150 mmHg or or ≤ 90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg, pulse ≥100 bpm or ≤ 40 bpm Those who have administered drug metabolizing enzyme inducing or inhibiting drugs such as barbiturates within 1 month before the first administration date Those who eat abnormal diets that may affect the absorption, distribution, metabolism, and excretion of investigational drugs, or those who consume foods that may affect drug metabolism Cyclosporine, non-steroidal anti-inflammatory drugs, terfenadine, astemizole, digitalis, glucocorticosteroids, adrenocorticotropic hormone, and drugs affecting the renin-angiotensin-aldosterone system (RAAS) should be avoided within 2 weeks prior to the first dose. If you have administered any prescription drugs or herbal preparations that may affect the characteristics of clinical trial drugs, including a person who has administered any over-the-counter drug (OTC) or vitamin preparation within 10 days (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, the investigator may participate in the clinical trial at the discretion of the investigator.) Those who participated in other clinical trials within 6 months prior to the first administration date and received administration (However, the criteria for termination of participation in other clinical trials is based on the last administration date and the next day is counted as 1 day.) Whole blood donation or component blood donation within 1 month before the first administration date, blood transfusion within 1 month, or those who cannot avoid blood donation from the time of written consent of the subject to the time of Post-visit study Those who have continuously consumed alcohol (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the first administration date or cannot abstain from drinking from the time of consent of the subject to the time of Post-visit study Smokers whose average smoking amount exceeds 10 cigarettes per day within 3 months prior to the first administration date and those who cannot quit smoking from 24 hours prior to administration in each period to the time of the last blood collection Those who have consumed food containing grapefruit (grapefruit) from 48 hours before the first administration to the time of Post-visit study or who cannot refrain from eating Those who consumed caffeine-containing foods (coffee, green tea, black tea, carbonated beverages, coffee milk, nutritional tonic drinks, etc.) from 24 hours before administration to the last blood sampling, or who could not refrain from taking them. During the period from 48 hours before the first administration to the time of Post-visit study, those who have performed strenuous exercise that exceeds the level of daily life or who cannot refrain from strenuous exercise From the time of consent of the subject until 2 weeks after the date of the last clinical drug administration, reliable methods of contraception (e.g., contraceptive administration and implantation or intrauterine device, sterilization procedure (vasectomy) A person who is not using an excision, tubal ligation, etc.) or blocking method (combined use of spermicide with condom, vaginal diaphragm for contraception, vaginal sponge, or cervical cap) Those who are judged by the principal investigator for reasons other than the above selection/exclusion criteria and are judged unsuitable for participation in this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MinGyu Park, MD, PhD
    Phone
    +43-269-8707
    Email
    mk_park@cbnuhctc.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults

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