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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.
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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 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 |
| 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 |
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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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| Drug |
Reference drug |
|
| 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 |