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The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WE 941 OD | Experimental |
| |
| Brotizolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WE941 OD tablets | Drug |
| ||
| Brotizolam |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours) | up to 24 hours after drug administration | |
| Cmax (maximum plasma concentration) | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 30 days | |
| tmax (time to maximum plasma concentration) | up to 24 hours after drug administration | |
| MRT (Mean residence time) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C020960 | brotizolam |
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|
|
| up to 24 hours after drug administration |