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This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.
To healthy male subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Reference drug: D308 10mg Tab. / Test drug: CKD-380 10mg Tab.
Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental |
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| B group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D308 10mg Tab. | Drug | D308 10mg Tab.1T single oral administration under fasting condition |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCt of CKD-380 and D308 | Area under the CKD-380/D308 concentration in blood-time curve from zero to the final | Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
| Cmax of CKD-380 and D308 | The maximum CKD-380/D308 concentration in blood sampling time t | Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seunghoon Han, Professor | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul ST. Mary's Hospital | 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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| CKD-380 10mg Tab. | Drug | CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition |
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| D004700 | Endocrine System Diseases |