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This study will be a single-center, randomized, single-dose, open-label, two-treatment, two-period, two-sequence crossover bioequivalence study to compare the rate and extent of absorption of WD-1602 granule formulation (WD Pharma) to the reference drug Pradaxa® capsule (BI, Germany) under fed conditions in healthy subjects.
The study will comprise of a medical Screening visit, two 2-night (3-day) Treatment Periods, 2 outpatient visits, and a Follow-up visit. Each Treatment visit will be separated by a washout of up to 7 days. The Follow-up visit will occur approximately 7 days (±1) following the last study drug administration. The duration of subject participation, including screening, will be approximately 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment T | Experimental | 30 minutes after the start of a standard breakfast, subjects will take one straw of WD-1602 Dabigatran Etexilate Mesylate Granules (150 mg) in 100 mL water as oral administration. |
|
| Treatment R | Active Comparator | 30 minutes after the start of a standard breakfast, subjects will receive a single Pradaxa® 150 mg capsule swallowed with 240 mL water as oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WD-1602 | Drug | dabigatran etexilate mesylate granules for oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | area under the plasma concentration-time curve from time 0 to time t | pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals. |
| AUC0-inf | area under the concentration-time curve from time 0 to time infinity | pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals. |
| Cmax | the maximum concentration | pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals. |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Pradaxa® |
| Drug |
dabigatran etexilate capsules |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |