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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2000-01-31

Brief Summary

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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

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Detailed Description

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The quarternary anticholinergic compound methantheline bromide (diethyl-methyl \[2-(9 xanthenyl carbonyloxy) ethyl\] ammonium bromide) is marketed to treat neurogenic bladder instability. In comparison with atropine, it influences the parasympathetic nervous transmission more by ganglionic rather than peripheral muscarinic receptor blockade. Clinical effects after single therapeutic doses of 50-100 mg last for about 6 hours which is longer than after atropine. The drug relaxes smooth muscles of the gastrointestinal and urogenital tract. Furthermore, it inhibits bronchial, salivary and sweat glands secretion, lowers the production of gastric juice and disturbs accommodation.

There are no data available on the pharmacokinetic properties of methantheline in man. However, 25-50 mg intravenous methantheline seem to be equivalent to 50-100 mg p.o. with regard to the pharmacodynamic effects \[Stille 1988\].

Vagantin® is marketed as coated tablets containing 50 mg methantheline bromide. Because of the particular properties of methantheline (narrow therapeutic range, obviously erratic, incomplete and irregular absorption) and because of the national and international recommendations concerning the registration of drugs, Vagantin® must be evaluated with regard to its pharmacokinetic properties at least relative to a non-formulated form.

Conditions

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Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test

Pharmacokinetics and -dynamics after single dose administration of 2 coated tablets Vagantin® (coated tablets of 50 mg methantheline bromide)

Group Type EXPERIMENTAL

blood sampling

Intervention Type PROCEDURE

blood sampling before and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 hours after administration of study medication

Vagantin®

Intervention Type DRUG

administration of 2 coated tablets Vagantin® (coated tablets of 50 mg methantheline bromide)

Measurement of salivation

Intervention Type PROCEDURE

Volume of salivary gland secretion was measured by chewing a 5 x 5 cm piece of PARAFILM "M"® (American Can Company, UK) for 5 min. Saliva was collected in glass tubes and the amount of the stimulated saliva was measured by weighing

Measurement of accommodation

Intervention Type PROCEDURE

Accommodation was measured with the optometer according to Schober (Velhagen 1972)

Pupillometry

Intervention Type PROCEDURE

Pupil function was assessed with the pupillograph (Compact Integrated Pupillograph, AMTech, Weinheim, Germany). The following data were obtained: pupil diameter, response to defined flash stimuli

Reference

Pharmacokinetics and -dynamics after single dose administration 100 ml methantheline solution (100 mg methantheline bromide)

Group Type ACTIVE_COMPARATOR

blood sampling

Intervention Type PROCEDURE

blood sampling before and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 hours after administration of study medication

methantheline solution

Intervention Type DRUG

administration 100 ml methantheline solution (100 mg methantheline bromide)

Measurement of salivation

Intervention Type PROCEDURE

Volume of salivary gland secretion was measured by chewing a 5 x 5 cm piece of PARAFILM "M"® (American Can Company, UK) for 5 min. Saliva was collected in glass tubes and the amount of the stimulated saliva was measured by weighing

Measurement of accommodation

Intervention Type PROCEDURE

Accommodation was measured with the optometer according to Schober (Velhagen 1972)

Pupillometry

Intervention Type PROCEDURE

Pupil function was assessed with the pupillograph (Compact Integrated Pupillograph, AMTech, Weinheim, Germany). The following data were obtained: pupil diameter, response to defined flash stimuli

Interventions

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blood sampling

blood sampling before and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 hours after administration of study medication

Intervention Type PROCEDURE

Vagantin®

administration of 2 coated tablets Vagantin® (coated tablets of 50 mg methantheline bromide)

Intervention Type DRUG

methantheline solution

administration 100 ml methantheline solution (100 mg methantheline bromide)

Intervention Type DRUG

Measurement of salivation

Volume of salivary gland secretion was measured by chewing a 5 x 5 cm piece of PARAFILM "M"® (American Can Company, UK) for 5 min. Saliva was collected in glass tubes and the amount of the stimulated saliva was measured by weighing

Intervention Type PROCEDURE

Measurement of accommodation

Accommodation was measured with the optometer according to Schober (Velhagen 1972)

Intervention Type PROCEDURE

Pupillometry

Pupil function was assessed with the pupillograph (Compact Integrated Pupillograph, AMTech, Weinheim, Germany). The following data were obtained: pupil diameter, response to defined flash stimuli

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes