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Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a multiple dose to healthy adult male volunteers in double blind manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WAL2014 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAL2014 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analyte in plasma (Cmax) | up to day 14 | |
| Time to reach maximum plasma concentration (tmax) | up to day 14 | |
| Area under the plasma concentration-time curve (AUC) | up to day 14 | |
| Urinary excretion rate | up to day 14 | |
| Minimum plasma concentration (Cmin) | up to day 14 | |
| Mean residence time (MRT) | up to day 14 | |
| Terminal half-life (t1/2) | up to day 14 | |
| Distribution volume | up to day 14 | |
| Total clearance | up to day 14 | |
| Number of subjects with adverse events | up to 22 days |
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Inclusion Criteria:
Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.
Exclusion Criteria:
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| ID | Term |
|---|---|
| C079885 | talsaclidine fumarate |
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| Drug |
|