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Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]talsaclidine, oral | Experimental | single dose of 20 mg oral solution |
|
| [14C]talsaclidine, iv | Active Comparator | single dose of 20 mg intravenous (iv) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]talsaclidine, oral | Drug |
| ||
| [14C]talsaclidine, iv |
| Measure | Description | Time Frame |
|---|---|---|
| [C14]-radioactivity concentration in blood | up to 96 hours after drug administration | |
| [C14]-radioactivity concentration in plasma | up to 96 hours after drug administration | |
| [C14]-radioactivity concentration in urine | up to 96 hours after drug administration | |
| Area under the plasma concentration-time curve (AUC) | up to 96 hours after drug administration | |
| Terminal half-life (t1/2) | up to 96 hours after drug administration | |
| Maximum concentration of the analyte in plasma (Cmax) | up to 96 hours after drug administration | |
| Time to reach maximum plasma concentration (tmax) | up to 96 hours after drug administration | |
| Absolute bioavailability based on AUC | up to 96 hours after drug administration | |
| Drug absorption (fa) based on radioactivity | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion (Ae) | up to 96 hours after drug administration | |
| Mean residence time (MRT) | up to 96 hours after drug administration | |
| Apparent clearance (CL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| up to 96 hours after drug administration |
| Apparent volume of distribution (Vz/f)) | up to 96 hours after drug administration |
| Plasma protein binding of the [14C] radioactivity | up to 96 hours after drug administration |
| Number of subjects with adverse events | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in electrocardiogram | up to 8 days after last drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after last drug administration |