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A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828 20/1.25mg

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CKD-828, D064, D702
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 - 54 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult aged ≥ 19 and <55 at screening Those who have a body mass index (BMI) of not less than 18.0 kg/m2 and not more than 30.5 kg/m2 and weigh not less than 55 kg A person who has no congenital or chronic disease within the last three years and has no pathological symptoms or findings as a result of medical examination A person who is deemed suitable for testing as a result of laboratory tests (hematological tests, hemochemistry tests, urinary tests, virus/bacterial tests, etc.) conducted by the tester according to the characteristics of the drug, vital signs, electrocardiogram tests, etc A person who has signed a written consent approved by the Chonbuk National University Hospital Clinical Trial Review Board (IRB) after fully explaining the purpose, contents, etc. of the test before participating in the test A person who has agreed not to donate sperm during the pre-clinical period and one month after taking the last clinical drug (non-hormonal contraceptive method: condom use, intrauterine device (IUD, IUS), tubular ligation, cervical cap, contraceptive diaphragm, etc.) A person who has the ability and will to participate during the pre-test period Exclusion Criteria: Clinically significant blood, kidneys (severe renal dysfunction, etc.), endocrine, respiratory, gastrointestinal, urology, cardiovascular (within one month of severe aortic stenosis, instability, or myocardial infarction), liver (severe hepatic dysfunction, biliary obstruction, bile congestion, etc.), mental, nerve or immune disease simple dental evidence A person who has a history of gastrointestinal diseases (e.g., esophageal diseases such as esophageal dysphagia or esophageal stenosis, Crohn's disease) or surgery (excluding simple appendectomy, hernia, or extraction surgery) that can affect drug absorption A person who shows the following figures as a result of performing an inspection laboratory inspection during screening ALT or AST > Twice the upper limit of the normal range CK> 3 times the upper limit of the normal range eGFR <60 mL/min/1.73 m2 using CKD-EPI formula Screening Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months (Beer (5%) 1 glass (250 mL) = 10 g, Soju (20%) 1 glass (50 mL) = 8 g, Wine (12%) 1 glass (125 mL) = 12 g) Smokers with 20 or more cigarettes per day within 6 months of screening A person who has taken another clinical trial drug or biological equivalence test drug within six months prior to the first administration of the clinical trial drug Person who falls under the following results of vital signs measurement during screening ☞ Those with systolic blood pressure of less than 90 mmHg, 140 mmHg or more, or diastolic blood pressure of less than 60 mmHg or 90 mmHg or more in the sedentary state A person who has a history of serious alcohol or drug misuse within one year of screening A person who has taken a drug known to significantly induce or inhibit drug metabolites within 30 days prior to the first administration of a drug for clinical trials A person who has taken prescription or non-prescription drugs within 10 days prior to the first administration of a clinical trial drug A person who has donated all blood within two months before the first administration of a clinical trial drug, or has donated blood components within one month, or received a blood transfusion within one month Those with severe acute/chronic medical and mental conditions that may increase risk or interfere with the interpretation of test results due to the administration and participation in clinical trial drugs A person who has overreaction to clinical trial drugs, the main ingredients and components of clinical trial drugs, or other dihydropyridine-based drugs Patients with hereditary angioedema or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists Shock patients (including cardiac shock) Pregnant or lactating women Other persons deemed inappropriate by the tester to participate in this test

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sequence 1

    Sequence 2

    Arm Description

    Period 1: D064, D702 - A single oral dose of 2 tablets Period 2: CKD-828 - A single oral dose of 1 tablet Period 3: D064, D702 - A single oral dose of 2 tablets Period 4: CKD-828 - A single oral dose of 1 tablet

    Period 1: CKD-828 - A single oral dose of 1 tablet Period 2: D064, D702 - A single oral dose of 2 tablets Period 3: CKD-828 - A single oral dose of 1 tablet Period 4: D064, D702 - A single oral dose of 2 tablets

    Outcomes

    Primary Outcome Measures

    AUCt of CKD-828
    Area under the concentration-time curve time zero to time
    Cmax of CKD-828
    Maximum plasma concentration of the drug

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2023
    Last Updated
    May 21, 2023
    Sponsor
    Chong Kun Dang Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05881707
    Brief Title
    A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828 20/1.25mg
    Official Title
    A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-828 in Healthy Volunteers Under Fasting Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 7, 2023 (Anticipated)
    Primary Completion Date
    August 19, 2023 (Anticipated)
    Study Completion Date
    August 26, 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

    5. Study Description

    Brief Summary
    A clinical trial to compare the pharmacokinetic and safety of CKD-828 20/1.25mg
    Detailed Description
    A randomized, open-label, single dose, 4-period replicate crossover study to evaluate the pharmacokinetic profiles and safety of CKD-828 in healthy volunteers under fasting conditions

    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
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    Period 1: D064, D702 - A single oral dose of 2 tablets Period 2: CKD-828 - A single oral dose of 1 tablet Period 3: D064, D702 - A single oral dose of 2 tablets Period 4: CKD-828 - A single oral dose of 1 tablet
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    Period 1: CKD-828 - A single oral dose of 1 tablet Period 2: D064, D702 - A single oral dose of 2 tablets Period 3: CKD-828 - A single oral dose of 1 tablet Period 4: D064, D702 - A single oral dose of 2 tablets
    Intervention Type
    Drug
    Intervention Name(s)
    CKD-828, D064, D702
    Intervention Description
    QD, PO
    Primary Outcome Measure Information:
    Title
    AUCt of CKD-828
    Description
    Area under the concentration-time curve time zero to time
    Time Frame
    Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour
    Title
    Cmax of CKD-828
    Description
    Maximum plasma concentration of the drug
    Time Frame
    Pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    54 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adult aged ≥ 19 and <55 at screening Those who have a body mass index (BMI) of not less than 18.0 kg/m2 and not more than 30.5 kg/m2 and weigh not less than 55 kg A person who has no congenital or chronic disease within the last three years and has no pathological symptoms or findings as a result of medical examination A person who is deemed suitable for testing as a result of laboratory tests (hematological tests, hemochemistry tests, urinary tests, virus/bacterial tests, etc.) conducted by the tester according to the characteristics of the drug, vital signs, electrocardiogram tests, etc A person who has signed a written consent approved by the Chonbuk National University Hospital Clinical Trial Review Board (IRB) after fully explaining the purpose, contents, etc. of the test before participating in the test A person who has agreed not to donate sperm during the pre-clinical period and one month after taking the last clinical drug (non-hormonal contraceptive method: condom use, intrauterine device (IUD, IUS), tubular ligation, cervical cap, contraceptive diaphragm, etc.) A person who has the ability and will to participate during the pre-test period Exclusion Criteria: Clinically significant blood, kidneys (severe renal dysfunction, etc.), endocrine, respiratory, gastrointestinal, urology, cardiovascular (within one month of severe aortic stenosis, instability, or myocardial infarction), liver (severe hepatic dysfunction, biliary obstruction, bile congestion, etc.), mental, nerve or immune disease simple dental evidence A person who has a history of gastrointestinal diseases (e.g., esophageal diseases such as esophageal dysphagia or esophageal stenosis, Crohn's disease) or surgery (excluding simple appendectomy, hernia, or extraction surgery) that can affect drug absorption A person who shows the following figures as a result of performing an inspection laboratory inspection during screening ALT or AST > Twice the upper limit of the normal range CK> 3 times the upper limit of the normal range eGFR <60 mL/min/1.73 m2 using CKD-EPI formula Screening Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months (Beer (5%) 1 glass (250 mL) = 10 g, Soju (20%) 1 glass (50 mL) = 8 g, Wine (12%) 1 glass (125 mL) = 12 g) Smokers with 20 or more cigarettes per day within 6 months of screening A person who has taken another clinical trial drug or biological equivalence test drug within six months prior to the first administration of the clinical trial drug Person who falls under the following results of vital signs measurement during screening ☞ Those with systolic blood pressure of less than 90 mmHg, 140 mmHg or more, or diastolic blood pressure of less than 60 mmHg or 90 mmHg or more in the sedentary state A person who has a history of serious alcohol or drug misuse within one year of screening A person who has taken a drug known to significantly induce or inhibit drug metabolites within 30 days prior to the first administration of a drug for clinical trials A person who has taken prescription or non-prescription drugs within 10 days prior to the first administration of a clinical trial drug A person who has donated all blood within two months before the first administration of a clinical trial drug, or has donated blood components within one month, or received a blood transfusion within one month Those with severe acute/chronic medical and mental conditions that may increase risk or interfere with the interpretation of test results due to the administration and participation in clinical trial drugs A person who has overreaction to clinical trial drugs, the main ingredients and components of clinical trial drugs, or other dihydropyridine-based drugs Patients with hereditary angioedema or patients with a history of angioedema when treated with ACE inhibitors or angiotensin II receptor antagonists Shock patients (including cardiac shock) Pregnant or lactating women Other persons deemed inappropriate by the tester to participate in this test
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mingul Kim, Ph.D
    Phone
    +82-63-259-3480
    Email
    mgkim@jbcp.kr

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial to Compare the Pharmacokinetic and Safety of CKD-828 20/1.25mg

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