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

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Propranolol; Drug: Talsaclidine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talsaclidine with Propranol	Drug: Propranolol; Drug: Talsaclidine
Active Comparator: Propranolol	Drug: Propranolol
Active Comparator: Talsaclidine	Drug: Talsaclidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Airway resistance (Raw)	Up to 8 hours after drug administration
Specific conductance (SGaw)	Up to 8 hours after drug administration
Forced expiratory volume in 1 sec (FEV1)	Up to 8 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with clinically significant findings in vital signs	Up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests	Up to 8 days after last drug administration
Number of participants with adverse events	Up to 8 days after last drug administration
Cmax (maximum measured concentration of the analyte in plasma)	Up to 12 hours after drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)	Up to 12 hours after drug administration
AUC (area under the plasma concentration versus time curve)	Up to 12 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1999
• Primary Completion (Actual): February 1, 2000

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 506.114