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The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brotizolam tablet | Active Comparator | Brotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively |
|
| Lendormin tablet | Experimental | Lendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lendormin tablet | Drug | Lendormin tablet 250mc is administrated and compared |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Peak drug concentration obtained directly from the data without interpolation | One month | |
| kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration | One month | |
| Tmax:Time to peak drug concentration obtained directly from the data without interpolation | One month | |
| T 1/2: Plasma half-life estimated by (0.693/kel) | One month | |
| MRT : Mean residence time | One month | |
| AUMC : Area under the ( first) moment plasma concentration - time curve | One month | |
| AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule | One month | |
| AUC 0- : Area under the plasma concentration-time curve from time zero to infinity determined by the trapezoidal rule and extrapolated to infinity estimated by the last quantifiable concentration (Cn) divided by kel | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | one month | |
| heart rate | one month | |
| body temperature |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 263.511.1 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
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| ID | Term |
|---|---|
| C020960 | brotizolam |
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| Brotizolam tablet |
| Drug |
Brotizolam tablet 250mc is administrated and compared |
|
| One month |
| 12 Laed ECG, Lab Test ( Hematocrit, WBC count with differential, RBC count and platelet count ; SGOT ( AST), SGPT (ALT) , alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine,uric acid, total cholesterol and TG) | One month |