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

Phase 1 Completed 12 enrolled University Medicine Greifswald RIEMSER Arzneimittel GmbH · collab

RandomizedCrossoverOpen-labelBasic science

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

Timeline

Start: 1999-10
Primary completion: 1999-11
Completion: 2000-01

Outcome

Missed primary endpoint

paper There was no pharmacokinetic (PK) bioequivalence of methantheline IR and SOL. PMID 22527350 ↗

Publications

Muller C, Lotsch J, Giessmann T, Franke G, Walter R, Zschiesche M, Siegmund W. Relative bioavailability and pharmacodynamic effects of methantheline compared with atropine in healthy subjects. Eur J Clin Pharmacol. 2012 Nov;68(11):1473-81. doi: 10.1007/s00228-012-1286-6. Epub 2012 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	methantheline	Small molecule	100 mg	Oral

Indications

No indication recorded.