Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

Study Overview
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Brief Summary
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The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults.

Official Title
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A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-387
* Drug: D635


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 19 to 55 years Females must be menopause or 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 aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 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 Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization 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: 55 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: D635 Period 2: CKD-387 | Drug: CKD-387<br>* Test drug<br>Drug: D635<br>* Reference drug<br>|
| Experimental: Group 2<br>Period 1: CKD-387 Period 2: D635 | Drug: CKD-387<br>* Test drug<br>Drug: D635<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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