search
Back to results

Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults (CKD-378)

Primary Purpose

Type II Diabetes

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CKD-378 (low-dose)
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes

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 50kg(woman) Body mass index (BMI) of 18.5 to 27.0kg/m2 If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized. Those who agree to contraception from the first Investigational Product (IP) dosing day till 28days 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 clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haematooncology disorder, Cardiovascular disorder or Psychical disorder. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who have significant disease or medical history of urinary infection. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. Those who have tested inappropriate in screening test 28 days prior to IP administration. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.25 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 "Positive" or "Reactive" test result of Hepatitis B & C, HIV, rapid plasma reagin test (RPR) Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg. Those who has a drug abuse history within one year or positive reaction on urine drug screening test. Woman who are pregnant or breastfeeding Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who have used following drugs that can interfere with the study or have impact on safety of the subject. Ethical drug (ETC), herbal medicinal preparations within 14 days before the first dosing date Over the counter (OTC), vitamins, health supplement within 7 days before the first dosing date Depot injection or implantation within 30 days before the first dosing date Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days Those who have received blood transfusion in 30 days 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: D745, D150, D029 - A single oral dose of 3tablets under food intake condition Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition

    Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition

    Outcomes

    Primary Outcome Measures

    area under the curve (AUC)t of CKD-378
    Area under the concentration-time curve time zero to time
    Cmax of CKD-378
    Maximum plasma concentration of the drug

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    May 30, 2023
    Sponsor
    Chong Kun Dang Pharmaceutical
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05881213
    Brief Title
    Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
    Acronym
    CKD-378
    Official Title
    A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 24, 2023 (Anticipated)
    Primary Completion Date
    June 14, 2023 (Anticipated)
    Study Completion Date
    July 2, 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-378
    Detailed Description
    A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type II Diabetes

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    Period 1: D745, D150, D029 - A single oral dose of 3tablets under food intake condition Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition
    Intervention Type
    Drug
    Intervention Name(s)
    CKD-378 (low-dose)
    Intervention Description
    Quaque day (QD), PO
    Primary Outcome Measure Information:
    Title
    area under the curve (AUC)t of CKD-378
    Description
    Area under the concentration-time curve time zero to time
    Time Frame
    Pre-dose(0 hour) to 48 hours
    Title
    Cmax of CKD-378
    Description
    Maximum plasma concentration of the drug
    Time Frame
    Pre-dose(0 hour) to 48 hours

    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 50kg(woman) Body mass index (BMI) of 18.5 to 27.0kg/m2 If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized. Those who agree to contraception from the first Investigational Product (IP) dosing day till 28days 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 clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haematooncology disorder, Cardiovascular disorder or Psychical disorder. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration. Those who have significant disease or medical history of urinary infection. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin. Those who have tested inappropriate in screening test 28 days prior to IP administration. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.25 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 "Positive" or "Reactive" test result of Hepatitis B & C, HIV, rapid plasma reagin test (RPR) Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg. Those who has a drug abuse history within one year or positive reaction on urine drug screening test. Woman who are pregnant or breastfeeding Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who have used following drugs that can interfere with the study or have impact on safety of the subject. Ethical drug (ETC), herbal medicinal preparations within 14 days before the first dosing date Over the counter (OTC), vitamins, health supplement within 7 days before the first dosing date Depot injection or implantation within 30 days before the first dosing date Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days Those who have received blood transfusion in 30 days 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
    Min Soo Park, M.D.
    Phone
    +8-2-2228-0401
    Email
    MINSPARK@YUHS.AC

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults

    We'll reach out to this number within 24 hrs