Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemigliptin
Dapagliflozin
Empagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Healthy male adults at age between 19 to 55 at the time of the screening
- Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
- Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
- subjects who is consented in writing to be sure to comply with the requirements of the clinical trial
Exclusion Criteria:
- Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
- Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
- Subject who had infection disease or serious injury within 21 days before the randomization
- Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
- Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
- Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
- Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
- Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
- subject who drinks the average amount per week exceeding 140 g of alcohol
- Subject whose daily average smoking amount exceeds 20 pieces per day
- Average daily grapefruit juice intake exceeding 2 cups
- Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
- Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
- Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
- Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
- Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
- Subject who have clinically significant abnormalities in other clinical tests
- Subject with clinically significant abnormal ECG findings
- Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment
Sites / Locations
- LG chem
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
gemigliptin
dapagliflozin
gemigliptin and dapagliflozin
empagliflozin
gemigliptin and empagliflozin
Arm Description
gemigliptin single dose
dapagliflozin single dose
co-administration of gemigliptin and dapagliflozin
empagliflozin single dose
co-administration of gemigliptin and empagliflozin
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
AUCτ
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Css,max
Secondary Outcome Measures
tss,max of gemigliptin, dapagliflozin, empagliflozin
tss,max
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Css,min
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
AUCτ
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Css,max
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Css,min
metabolic ratio of gemigliptin
metabolic ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03565458
Brief Title
Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
Official Title
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Anticipated)
Study Completion Date
December 22, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
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
gemigliptin,SGLT-2i DDI study
Detailed Description
LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin & dapagliflozin and gemigliptin & empagliflozin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gemigliptin
Arm Type
Experimental
Arm Description
gemigliptin single dose
Arm Title
dapagliflozin
Arm Type
Experimental
Arm Description
dapagliflozin single dose
Arm Title
gemigliptin and dapagliflozin
Arm Type
Experimental
Arm Description
co-administration of gemigliptin and dapagliflozin
Arm Title
empagliflozin
Arm Type
Experimental
Arm Description
empagliflozin single dose
Arm Title
gemigliptin and empagliflozin
Arm Type
Experimental
Arm Description
co-administration of gemigliptin and empagliflozin
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Other Intervention Name(s)
zemiglo
Intervention Description
zemiglo 50mg,LG Chem
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
forxiga
Intervention Description
forxiga, dapagliflozin 10mg
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
jardiance
Intervention Description
jardiance 25mg, empagliflozin
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
Description
AUCτ
Time Frame
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Description
Css,max
Time Frame
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary Outcome Measure Information:
Title
tss,max of gemigliptin, dapagliflozin, empagliflozin
Description
tss,max
Time Frame
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Description
Css,min
Time Frame
day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
Description
AUCτ
Time Frame
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Description
Css,max
Time Frame
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Description
Css,min
Time Frame
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Title
metabolic ratio of gemigliptin
Description
metabolic ratio
Time Frame
day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
10. Eligibility
Sex
Male
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 male adults at age between 19 to 55 at the time of the screening
Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
subjects who is consented in writing to be sure to comply with the requirements of the clinical trial
Exclusion Criteria:
Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
Subject who had infection disease or serious injury within 21 days before the randomization
Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
subject who drinks the average amount per week exceeding 140 g of alcohol
Subject whose daily average smoking amount exceeds 20 pieces per day
Average daily grapefruit juice intake exceeding 2 cups
Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
Subject who have clinically significant abnormalities in other clinical tests
Subject with clinically significant abnormal ECG findings
Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jungryul kim, doctor
Organizational Affiliation
samsung seoul medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LG chem
City
Seoul
State/Province
Gangseo-Gu
ZIP/Postal Code
07795
Country
Korea, Republic of
12. IPD Sharing Statement
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Gemigliptin, Dapagliflozin, Empagliflozin DDI Study
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