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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 under fed condition in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
|
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| Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-387 | Drug | Test drug |
| |
| D635 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Metformin | Maximum plasma concentration of Metformin | 0 hour ~ 48 hour after drug administration |
| AUClast of Metformin | Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration | 0 hour ~ 48 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Metformin | Area under the plasma concentration of Metformin-time curve from time zero to infinity | 0 hour ~ 48 hour after drug administration |
| Tmax of Metformin | Time to reach maximum (peak) plasma concentration of Metformin following drug administration |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park, Ph.D. M.D. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Reference drug |
|
| 0 hour ~ 48 hour after drug administration |
| t1/2 of Metformin | Half-life of Metformin | 0 hour ~ 48 hour after drug administration |
| CL/F of Metformin | Apparent clearance of Metformin | 0 hour ~ 48 hour after drug administration |
| Vd/F of Metformin | Apparent volume of distribution of Metformin | 0 hour ~ 48 hour after drug administration |
| D004700 | Endocrine System Diseases |