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Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Propranolol (Drug); Talsaclidine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances

Clinical Details

Official title: Effects on the Airway Lumen of Single Oral Doses of Talsaclidine (12, 24, 48 and 60 mg) in Combination With a Single Oral Doses of 160 mg Propranolol in Comparison to the Effects of the Monosubstances (60 mg Talsaclidine and 160 mg Propranolol) in Healthy Elderly Male Volunteers (Partially Randomised, Open Label, Intraindividual Comparison)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Airway resistance (Raw)

Specific conductance (SGaw)

Forced expiratory volume in 1 sec (FEV1)

Secondary outcome:

Number of participants with clinically significant findings in vital signs

Number of participants with clinically significant findings in laboratory tests

Number of participants with adverse events

Cmax (maximum measured concentration of the analyte in plasma)

tmax (time from dosing to maximum measured concentration of the analyte in plasma)

AUC (area under the plasma concentration versus time curve)

Eligibility

Minimum age: 50 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

Inclusion Criteria: All participants in the study should be healthy males, range from 50 to 65 years of age and be within +- 20% of their normal weight (Broca-Index). Exclusion Criteria:

- Volunteers will be excluded from the study if the result of the medical examination

or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values

- Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60

beats/min

- Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80

mg propranolol

- Volunteers with Raw-values higher than their predicted normal upper limit

- Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular,

metabolic, immunological or hormonal disorders

- Volunteers with disease of the central nervous system (such as epilepsy) or with

psychiatric disorders

- Volunteers with known history of orthostatic hypotension, fainting spells or

blackouts

- Volunteers with chronic or relevant acute infections

- Volunteers with history of allergy / hypersensitivity (including drug allergy) which

is deemed relevant to the trial as judged by the investigator

- Volunteers who have taken a drug with a long half life (>=24 hours) within at least

one month or less than ten half lives of the respective drug before enrolment in the study

- Volunteers who received any other drugs which might influence the results of the

trial during the week prior the start of the study

- Volunteers who have participated in another study with an investigational drug

within the last 2 month preceding this study

- Volunteers who are unable to refrain from smoking on the 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

- Volunteers who have donated blood (>=100ml) within the last 4 weeks

- Volunteers who participated in excessive physical activities (e. g. competitive

sports) within the last week before the study

Locations and Contacts

Additional Information

Starting date: November 1999
Last updated: October 13, 2014

Page last updated: August 23, 2015

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