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A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2)

Primary Purpose

Dyslipidemias

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CKD-391(2)
CKD-331, D337
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring CKD-391, CKD-391(2)

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2 Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery Patients with the following diseases Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit Patients with severe liver failure or biliary obstruction and bile congestion Patients with muscular disease, rhabdomyolysis, or persons with a past history Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs Patients with renal impairment or a history of in and patients with severe renal dysfunction Patients with a history of muscle toxicity to other statin drugs or fibrate drugs 7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8. Those who have hypersensitivity to the main constituents or components of the investigational drug 9. Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests 10. Woman who are pregnant or breastfeeding 11. Those who are deemed insufficient to participate in clinical study by investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sequence 1

    Sequence 2

    Arm Description

    Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition

    Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition

    Outcomes

    Primary Outcome Measures

    AUCt of CKD-391(2)
    Area under the concentration-time curve time zero to time
    Cmax of CKD-391(2)
    Maximum plasma concentration of the drug

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Chong Kun Dang Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088017
    Brief Title
    A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2)
    Official Title
    A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391(2) and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 23, 2023 (Anticipated)
    Primary Completion Date
    March 7, 2024 (Anticipated)
    Study Completion Date
    April 22, 2024 (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 and evaluate the safety and pharmacokinetics of CKD-391(2)
    Detailed Description
    A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391(2) and co-administration of CKD-331 and D337 in healthy adult volunteers

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemias
    Keywords
    CKD-391, CKD-391(2)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 2: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 4: CKD-391(2) - A single oral dose of 1 tablet under fasting condition
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    Period 1: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 3: CKD-391(2) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
    Intervention Type
    Drug
    Intervention Name(s)
    CKD-391(2)
    Intervention Description
    QD, PO
    Intervention Type
    Drug
    Intervention Name(s)
    CKD-331, D337
    Intervention Description
    QD, PO
    Primary Outcome Measure Information:
    Title
    AUCt of CKD-391(2)
    Description
    Area under the concentration-time curve time zero to time
    Time Frame
    Pre-dose(0 hour) to 72hours
    Title
    Cmax of CKD-391(2)
    Description
    Maximum plasma concentration of the drug
    Time Frame
    Pre-dose(0 hour) to 72hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2 Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery Patients with the following diseases Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit Patients with severe liver failure or biliary obstruction and bile congestion Patients with muscular disease, rhabdomyolysis, or persons with a past history Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs Patients with renal impairment or a history of in and patients with severe renal dysfunction Patients with a history of muscle toxicity to other statin drugs or fibrate drugs 7. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8. Those who have hypersensitivity to the main constituents or components of the investigational drug 9. Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests 10. Woman who are pregnant or breastfeeding 11. Those who are deemed insufficient to participate in clinical study by investigators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyeon Soo Park, M.D.
    Phone
    +82-10-6455-2016
    Email
    wefe6405@bumin.co.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391(2)

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