Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults

Study Overview
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Brief Summary
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A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers

Official Title
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A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-370 With D745 in Healthy Volunteers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-370
* Drug: D745


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 19 to 55 years Females who are not pregnant or breastfeeding or who have surgical infertility Signed informed consent form Other inclusion criteria, as defined in the protocol Exclusion Criteria: History of clinically significant hepatic, renal, nervous, immune, respiratory, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder Clinical laboratory test values are outside the accepted normal range at Screening aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.5 times the upper limit of the normal range Total Bilirubin > 1.5 times the upper limit of the normal range creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease) Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge. Participated in a clinical trial within 90 days prior to first IP dosing Not eligible to participate for the study at the discretion of Investigator Other exclusive inclusion criteria, as defined in the protocol

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Period 1: D745 Period 2: CKD-370 | Drug: CKD-370<br>* Test drug<br>Drug: D745<br>* Reference drug<br>|
| Experimental: Group B<br>Period 1: CKD-370 Period 2: D745 | Drug: CKD-370<br>* Test drug<br>Drug: D745<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of Empagliflozin | Area under the plasma concentration-time curve to last concentration of Empagliflozin | 0 hour   48 hour after drug administration | 
| Cmax of Empagliflozin | Maximum plasma concentration of Empagliflozin | 0 hour   48 hour after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Empagliflozin | Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin | 0 hour   48 hour after drug administration | 
| Tmax of Empagliflozin | Time to maximum plasma concentration of Empagliflozin | 0 hour   48 hour after drug administration | 
| T1/2 of Empagliflozin | Half-life of Empagliflozin | 0 hour   48 hour after drug administration | 
| CL/F of Empagliflozin | Apparent clearance of Empagliflozin | 0 hour   48 hour after drug administration | 
| Vd/F of Empagliflozin | Apparent volume of distribution of Empagliflozin | 0 hour   48 hour after drug administration |