A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
Primary Purpose
Type2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-375
D390
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Healthy adult who is 19 ~ 55 years at the time of screening
- Body weight more than 55 kg for male and more than 50kg for female
- BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
- Females must be menopause or surgical infertility
- Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
- Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
Exclusion Criteria:
- Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
- Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product
- Subjects who have a significant urinary tract infection or have such a history
- Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
- Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)
Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
- AST, ALT> UNL(Upper Normal Limit)x1.25
- Total bilirubin > UNL(Upper Normal Limit)x1.5
- eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
- Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
- Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
- Pregnant or lactating women
- Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
Subjects who took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator
- Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug
- Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
- Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product
- Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
- Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
- Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
Sites / Locations
- Yonsei University Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Period 1: D390 Period 2: CKD-375
Period 1: CKD-375 Period 2: D390
Outcomes
Primary Outcome Measures
Cmax of D390 and CKD-375
Maximum plasma concentration of D390 and CKD-375
AUClast of D390 and CKD-375
Area under the plasma concentration-time curve to last concentration of D390 and CKD-375
Secondary Outcome Measures
AUCinf of D390 and CKD-375
Area under the plasma concentration-time curve from zero to infinity concentration of D390 and CKD-375
Tmax of D390 and CKD-375
Time to maximum plasma concentration of D390 and CKD-375
t1/2 of D390 and CKD-375
Half-life of D390 and CKD-375
Vd/F of D390 and CKD-375
Apparent volume of distribution of D390 and CKD-375
CL/F of D390 and CKD-375
Apparent clearance of D390 and CKD-375
Full Information
NCT ID
NCT04221360
First Posted
January 6, 2020
Last Updated
January 6, 2020
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04221360
Brief Title
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
Official Title
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2020 (Anticipated)
Primary Completion Date
March 6, 2020 (Anticipated)
Study Completion Date
June 8, 2020 (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
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375.
Detailed Description
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: D390
Period 2: CKD-375
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: CKD-375
Period 2: D390
Intervention Type
Drug
Intervention Name(s)
CKD-375
Intervention Description
Test drug, QD, PO
Intervention Type
Drug
Intervention Name(s)
D390
Intervention Description
Reference drug, QD, PO
Primary Outcome Measure Information:
Title
Cmax of D390 and CKD-375
Description
Maximum plasma concentration of D390 and CKD-375
Time Frame
0(predose)~48 hours
Title
AUClast of D390 and CKD-375
Description
Area under the plasma concentration-time curve to last concentration of D390 and CKD-375
Time Frame
0(predose)~48 hours
Secondary Outcome Measure Information:
Title
AUCinf of D390 and CKD-375
Description
Area under the plasma concentration-time curve from zero to infinity concentration of D390 and CKD-375
Time Frame
0(predose)~48 hours
Title
Tmax of D390 and CKD-375
Description
Time to maximum plasma concentration of D390 and CKD-375
Time Frame
0(predose)~48 hours
Title
t1/2 of D390 and CKD-375
Description
Half-life of D390 and CKD-375
Time Frame
0(predose)~48 hours
Title
Vd/F of D390 and CKD-375
Description
Apparent volume of distribution of D390 and CKD-375
Time Frame
0(predose)~48 hours
Title
CL/F of D390 and CKD-375
Description
Apparent clearance of D390 and CKD-375
Time Frame
0(predose)~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 who is 19 ~ 55 years at the time of screening
Body weight more than 55 kg for male and more than 50kg for female
BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
Females must be menopause or surgical infertility
Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
Exclusion Criteria:
Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product
Subjects who have a significant urinary tract infection or have such a history
Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)
Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
AST, ALT> UNL(Upper Normal Limit)x1.25
Total bilirubin > UNL(Upper Normal Limit)x1.5
eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
Pregnant or lactating women
Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
Subjects who took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator
Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug
Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product
Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Soo Park, M.D., Ph.D.
Phone
+82-2-2228-0401
Email
minspark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Soo Park, M.D., Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Severance Hospital
City
Soeul
Country
Korea, Republic of
12. IPD Sharing Statement
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A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
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