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A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-370 | Drug | Test drug |
| |
| D745 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Empagliflozin | Area under the plasma concentration-time curve to last concentration of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Cmax of Empagliflozin | Maximum plasma concentration of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Empagliflozin | Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Tmax of Empagliflozin | Time to maximum plasma concentration of Empagliflozin |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant hepatic, renal, nervous, immune, respiratory, digestive, urinary, 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 first 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Sang Yu, Ph.D. M.D. | Contact | +82-2-2072-1920 | ||
| Deok Yong Yoon | Contact | +82-2-2072-1930 | dyyoon18@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, Ph.D. M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 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 Empagliflozin | Half-life of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| CL/F of Empagliflozin | Apparent clearance of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Vd/F of Empagliflozin | Apparent volume of distribution of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| D004700 | Endocrine System Diseases |