Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

Recruitment & Eligibility

Inclusion Criteria

Healthy males
Age range from 50 to 65 years
Participants should be within 20% of their normal weight (Broca-Index)
Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria

Results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Disease of the central nervous system (such as epilepsy) or with psychiatric disorders
Known history of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (≥ 24 hours) within one month before enrolment in the study
Intake of any other drugs which might influence the results of the trial during the week previous the start of the study
Participation in another study with an investigational drug within the last 2 months preceding this study
Unability to refrain from smoking on study days
Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
Volunteers who drink more than 40 g of alcohol per day
Volunteers who are dependent on drugs
Blood donation ((≥ 100 ml) within the last 4 weeks
Excessive physical activities (e.g. competitive sports) within the last week before the study

Study & Design

Arm && Interventions

Group	Intervention	Description
[14C]talsaclidine, iv	[14C]talsaclidine, iv	single dose of 20 mg intravenous (iv) infusion
[14C]talsaclidine, oral	[14C]talsaclidine, oral	single dose of 20 mg oral solution

Primary Outcome Measures

Name	Time	Method
[C14]-radioactivity concentration in plasma	up to 96 hours after drug administration
Maximum concentration of the analyte in plasma (Cmax)	up to 96 hours after drug administration
Drug absorption (fa) based on radioactivity	up to 96 hours after drug administration
[C14]-radioactivity concentration in urine	up to 96 hours after drug administration
Terminal half-life (t1/2)	up to 96 hours after drug administration
Time to reach maximum plasma concentration (tmax)	up to 96 hours after drug administration
[C14]-radioactivity concentration in blood	up to 96 hours after drug administration
Absolute bioavailability based on AUC	up to 96 hours after drug administration
Area under the plasma concentration-time curve (AUC)	up to 96 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Number of subjects with clinically significant findings in electrocardiogram	up to 8 days after last drug administration
Apparent clearance (CL)	up to 96 hours after drug administration
Plasma protein binding of the [14C] radioactivity	up to 96 hours after drug administration
Urinary excretion (Ae)	up to 96 hours after drug administration
Number of subjects with adverse events	up to 8 days after last drug administration
Apparent volume of distribution (Vz/f))	up to 96 hours after drug administration
Mean residence time (MRT)	up to 96 hours after drug administration
Number of subjects with clinically significant findings in vital signs	up to 8 days after last drug administration	blood pressure, pulse rate
Number of subjects with clinically significant findings in laboratory tests	up to 8 days after last drug administration

Recruitment & Eligibility