The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.

Official Title
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A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-375
* Drug: D387


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, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder Clinical laboratory test values are outside the accepted normal range at Screening 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 1st 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 1<br>Period 1: D387 (reference drug) Period 2: CKD-387 (test drug) | Drug: CKD-375<br>* Test drug<br>Drug: D387<br>* Reference drug<br>|
| Experimental: Group 2<br>Period 1: CKD-387 (test drug) Period 2: D387 (reference drug) | Drug: CKD-375<br>* Test drug<br>Drug: D387<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity | AUCinf of Empagliflozin | 0 hour   48 hour after drug administration | 
| Area under the plasma concentration of Metformin-time curve from time zero to infinity | AUCinf of Metformin | 0 hour   48 hour after drug administration | 
| Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration | Tmax of Empagliflozin | 0 hour   48 hour after drug administration | 
| Time to reach maximum (peak) plasma concentration of Metformin following drug administration | Tmax of Metformin | 0 hour   48 hour after drug administration | 
| Half-life of Empagliflozin | t1/2 of Empagliflozin | 0 hour   48 hour after drug administration | 
| Half-life of Metformin | t1/2 of Metformin | 0 hour   48 hour after drug administration | 
| Apparent clearance of Empagliflozin | CL/F of Empagliflozin | 0 hour   48 hour after drug administration | 
| Apparent clearance of Metformin | CL/F of Metformin | 0 hour   48 hour after drug administration | 
| Apparent volume of distribution of Empagliflozin | Vd/F of Empagliflozin | 0 hour   48 hour after drug administration | 
| Apparent volume of distribution of Metformin | Vd/F of Metformin | 0 hour   48 hour after drug administration |