Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution

• Status: Completed
• Trial end date: 2000-01-01
• Target enrollment: 0
• Participant gender: All

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 methantheline bromide solution (Reference)

The secondary objectives of the study are:

• To determine elimination the half-life of methantheline bromide

• To describe the effects of Test and Reference on salivation, accommodation, pupil response, blood pressure and heart rate

• to assess frequency and intensity of adverse drug reactions

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medicine Greifswald
• Collaborator: RIEMSER Arzneimittel GmbH
• Treatments: Bromides; Methantheline; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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