Status:
COMPLETED
Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution
Lead Sponsor:
University Medicine Greifswald
Collaborating Sponsors:
RIEMSER Arzneimittel GmbH
Conditions:
Neurogenic Bladder
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is: •To describe extent and rate of absorption of methantheline after single oral dose administration of Vagantin® coated tablets (Test) in comparison to a methanth...
Detailed Description
The quarternary anticholinergic compound methantheline bromide (diethyl-methyl \[2-(9 xanthenyl carbonyloxy) ethyl\] ammonium bromide) is marketed to treat neurogenic bladder instability. In compariso...
Eligibility Criteria
Inclusion
- age: 18 - 45 years
- sex: male and female
- ethnic origin: Caucasian
- body weight: ±20 % of normal weight (Broca)
- good health as evidenced by the results of the clinical examination and the laboratory check-up which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- written informed consent
Exclusion
- known hypersensitivity to the investigational products or to their adjuvants
- pollakisurie of cardial and renal reasons
- megacolon
- atonia of the gastrointestinal tract
- atonia or hypotonia of the urinary bladder
- tachycardiac arrhythmia
- subvesical bladder obstruction, especially benign prostatic hypertrophy
- narrow angle glaucoma
- glasses or contact lenses
- history of gastrointestinal diseases (except appendectomy)
- history of renal and/or hepatic diseases
- any disease known to modify absorption, metabolism or excretion of the drug under investigation
- liability to orthostatic dysregulation, faintings, or blackouts
- alcohol consumption more than 40 g/day
- smokers of more than 10 cigarettes per day
- special or uniform nutritional habits, e.g. vegetarians or under-caloric diet
- less than 14 days after last acute disease
- less than 14 days after last systemic or local drug administration or 10 times the half life of the respective drug (except hormonal contraceptives)
- blood donation within the last two months
- blocking period due to another clinical study with investigational products; however at least 4 weeks after the end of the study or 10 times the half life of the respective drug
- lack of willingness or inability to co-operate adequately
- HIV and HBV and drug screening positive or not performed (in case of a positive HIV-test, the volunteers must be informed by a physician in a personal conversation)
- lactation and pregnancy test positive or not performed
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2000
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01429090
Start Date
October 1 1999
End Date
January 1 2000
Last Update
September 5 2011
Active Locations (1)
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1
Department of Clinical Pharmacology at the University of Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany, 17487