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To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers.
This study is to investigate drug-drug interaction between AJU-A51R1 and AJU-A51R2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ of AJU-A51R1 and AJU-A51R2 | Area Under Curve tau | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| Css,max of AJU-A51R1 and AJU-A51R2 | Cmax, steady state | predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-gul Kim | Jeonbuk University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Min-gul Kim | Jeonju | Korea | 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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| Treatment B | Drug | AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days |
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| Treatment C | Drug | AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days |
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| D004700 | Endocrine System Diseases |