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A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDG-17012® capsule | Experimental | RDG-17012 ® capsule(dabigatran etexilate tosylate) |
|
| Pradaxa® capsule | Active Comparator | Pradaxa® capsule(dabigatran etexilate mesylate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDG-17012 Capsule | Drug | Dabigatran Etexilate tosylate 150mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve(AUC) last of Total dabigatran and Free dabigatran | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 | |
| Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran | (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Gyeonggi-do | Seongnam-si | 13486 | South Korea |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Dabigatran Etexilate Mesylate 150 MG Oral Capsule |
| Drug |
Dabigatran Etexilate mesylate 150mg |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |