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

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 1999

Primary Completion Date

November 30, 1999

Study Completion Date

January 31, 2000

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

Trial Locations (1)

17487

Department of Clinical Pharmacology at the University of Greifswald, Greifswald

All Listed Sponsors
collaborator

RIEMSER Arzneimittel GmbH

UNKNOWN

lead

University Medicine Greifswald

OTHER