The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

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-387 and D484 under fed condition 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 D484 Under Fed Condition in Healthy Adults

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CKD-387
* Drug: D484


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: D484 Period 2: CKD-387 | Drug: CKD-387<br>* Test drug<br>Drug: D484<br>* reference drug<br>|
| Experimental: Group 2<br>Period 1: CKD-387 Period 2: D484 | Drug: CKD-387<br>* Test drug<br>Drug: D484<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 Metformin | Cmax of Metformin | 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 | 0 hour   48 hour after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Metformin following drug administration | Tmax of Metformin | 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 Metformin | CL/F of Metformin | 0 hour   48 hour after drug administration | 
| Apparent volume of distribution of Metformin | Vd/F of Metformin | 0 hour   48 hour after drug administration |