Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGGemigliptin
zemiglo 50mg,LG Chem
DRUGDapagliflozin
forxiga, dapagliflozin 10mg
DRUGEmpagliflozin
jardiance 25mg, empagliflozin
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male adults at age between 19 to 55 at the time of the screening 2. Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2 3. Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial 4. subjects who is consented in writing to be sure to comply with the requirements of the clinical trial
Exclusion criteria
1. 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 2. 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). 3. Subject who had infection disease or serious injury within 21 days before the randomization 4. Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 5. Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm 6. Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation 7. 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 8. Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization 9. subject who drinks the average amount per week exceeding 140 g of alcohol 10. Subject whose daily average smoking amount exceeds 20 pieces per day 11. Average daily grapefruit juice intake exceeding 2 cups 12. 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 13. 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 14. 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 15. Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test 16. Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history 17. Subject who have clinically significant abnormalities in other clinical tests 18. Subject with clinically significant abnormal ECG findings 19. Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | AUCτ |
| Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | Css,max |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | Css,min |
| Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | AUCτ |
| metabolic ratio of gemigliptin | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | metabolic ratio |
| minimum blood plasma concentration(Css,min) of gemigliptin metabolite | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | Css,min |
| Peak Plasma Concentration (Cmax)of gemigliptin metabolite | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | Css,max |
| tss,max of gemigliptin, dapagliflozin, empagliflozin | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | tss,max |
Countries
South Korea
Outcome results
None listed