Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects (CKD-371)
Primary Purpose
Type II Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-371
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Healthy adults volunteers aged between 19 and 45 years old at the time of screening
- Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
- Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Exclusion Criteria:
- Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
- Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
- Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
- Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
- Those with clinically significant active chronic disease
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
A person who has had one or more of the following results in screening tests including re-examination
- AST, ALT > UNL (upper normal limit) x 2.5
- Fasting glucose < 70 mg/dL
- Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) * (Wt in kg) / (72 * Cr))
- QTc > 470 msec as a result of ECG
- Urine-hCG test is positive(if it is limited to female subjects)
- Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
- Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
- Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose
- Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected
- Those who cannot eat the standard meal provided by the institution
- Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days
- Those who received a blood transfusion within 30 days prior to the first dose
- Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug
- Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product
- Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization
- Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization
- Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization
- Pregnant or childbearing potential and lactating women
- Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product
- Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude
Sites / Locations
- Korea University Anam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Arm Description
Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition. Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition.
Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition. Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition.
Outcomes
Primary Outcome Measures
AUCt of CKD-371, D745+D759
Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final
Cmax of CKD-371, D745+D759
The maximum CKD-388/D418 concentration in blood sampling time
Secondary Outcome Measures
Full Information
NCT ID
NCT05544214
First Posted
September 14, 2022
Last Updated
March 20, 2023
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05544214
Brief Title
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
Acronym
CKD-371
Official Title
An Open Label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)
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
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
Detailed Description
To healthy 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D745, D759 / Test drug: CKD-371
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition.
Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition.
Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition.
Intervention Type
Drug
Intervention Name(s)
CKD-371
Other Intervention Name(s)
D745, D759
Intervention Description
PO
Primary Outcome Measure Information:
Title
AUCt of CKD-371, D745+D759
Description
Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final
Time Frame
Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
Title
Cmax of CKD-371, D745+D759
Description
The maximum CKD-388/D418 concentration in blood sampling time
Time Frame
Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults volunteers aged between 19 and 45 years old at the time of screening
Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Exclusion Criteria:
Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
Those with clinically significant active chronic disease
Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
A person who has had one or more of the following results in screening tests including re-examination
AST, ALT > UNL (upper normal limit) x 2.5
Fasting glucose < 70 mg/dL
Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) * (Wt in kg) / (72 * Cr))
QTc > 470 msec as a result of ECG
Urine-hCG test is positive(if it is limited to female subjects)
Those who test positive for HBs Ag, HCV Ab, HIV Ab, or VDRL
Those who have taken prescription medicine (ETCs), including prescription drugs, within 14 days of the first dose
Those who have taken over-the-counter medicines (OTC) including herbal medicines within 7 days of the first dose
Clinically significant allergic diseases, mild allergic rhinitis that do not require medication, and allergic dermatitis can be selected
Those who cannot eat the standard meal provided by the institution
Those who donated whole blood within 60 days prior to the first dose or donated component blood within 20 days
Those who received a blood transfusion within 30 days prior to the first dose
Those who have participated in other clinical studies or bioequivalence studies within 6 months of the first dose and administered the investigational drug
Those who had taken any drug known as a strong inducer or inhibitor of drug-metabolizing enzymes within 30 days prior to the first dose of the investigational product
Those who have continuously consumed grapefruit juice or caffeine > 5 cups a day, or cannot refrain from intake during hospitalization
Consistently drinking alcohol > 30 days or unable to abstain from alcohol during hospitalization
Excessive smokers > 20 cigarettes non-daily or unable to quit smoking during hospitalization
Pregnant or childbearing potential and lactating women
Those who consent to the use of reliable contraception(contraceptive methods other than hormones: use of condoms, intrauterine devices (IUD, IUS), tubal ligation, cervical cap, contraceptive diaphragm, etc.) during the clinical trial and not to donate sperm until 2 month after the last administration of investigational product
Clinical laboratory test results and other reasons eg, a person who does not respond to requests and instructions, or who judges the investigator to be inappropriate to participate in the clinical trial with a non-cooperative attitude
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
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