Status:
COMPLETED
Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
50-65 years
Phase:
PHASE1
Brief Summary
Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02264054
Start Date
February 1 1999
Last Update
October 15 2014
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