Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

Study Overview
=================
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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Gemigliptin
* Drug: Dapagliflozin
* Drug: Empagliflozin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemigliptin<br>gemigliptin single dose | Drug: Gemigliptin<br>* zemiglo 50mg,LG Chem<br>* Other names: zemiglo;|
| Experimental: dapagliflozin<br>dapagliflozin single dose | Drug: Dapagliflozin<br>* forxiga, dapagliflozin 10mg<br>* Other names: forxiga;|
| Experimental: gemigliptin and dapagliflozin<br>co-administration of gemigliptin and dapagliflozin | Drug: Gemigliptin<br>* zemiglo 50mg,LG Chem<br>* Other names: zemiglo;Drug: Dapagliflozin<br>* forxiga, dapagliflozin 10mg<br>* Other names: forxiga;|
| Experimental: empagliflozin<br>empagliflozin single dose | Drug: Empagliflozin<br>* jardiance 25mg, empagliflozin<br>* Other names: jardiance;|
| Experimental: gemigliptin and empagliflozin<br>co-administration of gemigliptin and empagliflozin | Drug: Gemigliptin<br>* zemiglo 50mg,LG Chem<br>* Other names: zemiglo;Drug: Empagliflozin<br>* jardiance 25mg, empagliflozin<br>* Other names: jardiance;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin | AUCτ | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin | Css,max | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tss,max of gemigliptin, dapagliflozin, empagliflozin | tss,max | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin | Css,min | day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite | AUCτ | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| Peak Plasma Concentration (Cmax)of gemigliptin metabolite | Css,max | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| minimum blood plasma concentration(Css,min) of gemigliptin metabolite | Css,min | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours | 
| metabolic ratio of gemigliptin | metabolic ratio | day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours |