Abstract
The objective of these studies was to evaluate the pharmacokinetic profile, safety, and tolerability of mirabegron, a β3-adrenoceptor agonist for the treatment of overactive bladder, including food effects (low- or high-fat meals) and sex, in healthy East Asian subjects. In total, 5 pharmacokinetic studies of mirabegron were conducted in healthy East Asian subjects. Food effects were assessed in 3 randomized, single-dose studies in young Japanese male subjects (study 1), male and female subjects (study 2), and young Taiwanese male and female subjects (study 3). In the other 2 single- and multiple-dose studies in young Chinese male and female subjects (study 4 and study 5), mirabegron was administered as a single dose under fasted conditions. After the washout period, mirabegron was administered once daily under fed conditions for 8 days. Pharmacokinetic parameters were determined using noncompartmental methods. Safety and tolerability assessments included physical examinations, vital signs, 12-lead ECG, clinical laboratory tests (biochemistry, hematology, and urinalysis), and adverse event monitoring. After administration of single oral doses of mirabegron, exposure under fed conditions was lower than under fasted conditions in...Continue Reading
References
Sep 8, 2004·British Journal of Pharmacology·Tomoko KonishiMakoto Shimizu
Jan 5, 2005·BioFactors·Tomoko KonishiMakoto Shimizu
Jun 30, 2007·Neurourology and Urodynamics·Osamu Yamaguchi, Christopher R Chapple
Jan 18, 2008·Advanced Drug Delivery Reviews·Joseph M CustodioLeslie Z Benet
Jan 31, 2008·Clinical Pharmacology and Therapeutics·S P MyrandK D Wilner
Jan 25, 2012·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Shin TakusagawaTakashi Usui
Feb 10, 2012·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Raymond van TeijlingenTakashi Usui
Apr 19, 2012·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Shin TakusagawaTakashi Usui
Apr 24, 2012·Journal of Tropical Medicine·Henrique J P GomesEleidi A Chautard-Freire-Maia
Oct 16, 2012·Clinical Therapeutics·Walter KrauwinkelMarcel van Gelderen
Mar 19, 2013·Clinical Therapeutics·Jennifer LeeJames Keirns
Apr 30, 2013·Clinical Drug Investigation·Jennifer LeeJames Keirns
Nov 2, 2013·Clinical Drug Investigation·Hiromi IitsukaHideo Miyahara
Citations
Oct 24, 2015·British Journal of Pharmacology·E C AlexandreE Antunes
Nov 11, 2016·Drug Metabolism and Pharmacokinetics·Yuki NomuraTaiji Sawamoto
Dec 22, 2016·Expert Review of Clinical Pharmacology·Christopher R Chapple, Emad Siddiqui
Jun 6, 2018·Drugs·Emma D Deeks
Jul 18, 2017·Paediatric Drugs·Paweł Kroll