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

NCT01429090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-09-05

No results posted yet for this study

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

Conditions

  • Neurogenic Bladder

Interventions

PROCEDURE

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

DRUG

Vagantin®

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

DRUG

methantheline solution

administration 100 ml methantheline solution (100 mg methantheline bromide)

PROCEDURE

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

PROCEDURE

Measurement of accommodation

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

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

Sponsors & Collaborators

  • RIEMSER Arzneimittel GmbH

    collaborator UNKNOWN

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Primary Completion
1999-11-30
Completion
2000-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429090 on ClinicalTrials.gov