Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron

Phase 1 Completed 91 enrolled Astellas Pharma Inc

RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron formulations with three different release rates versus three doses of mirabegron administered intravenously; to study safety and side effects of the oral and IV doses of mirabegron.

Timeline

Start: 2009-04-30
Primary completion: 2009-07-13
Completion: 2009-07-13

Publications

Background Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J, van Marle S, Grunenberg N, Kowalski D, Drogendijk T, Moy S, Iitsuka H, van Gelderen M, Matsushima H, Sawamoto T. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a beta(3)-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	25 mg	Oral
Subject	Mirabegron	Other / unclassified	50 mg	Oral
Subject	Mirabegron	Other / unclassified	100 mg	Oral

Indications

No indication recorded.