Yi Li, Kaoru Toyama, Takafumi Nakatsu, Hitoshi Ishizuka, Hailan Wu, Guoying Cao, Jicheng Yu, Yu Wang, Xiaofen Liu, Beining Guo, Jufang Wu, Peimin Yu, Zhen Hong, Jing Zhang, Xiaojie Wu
INTRODUCTION: Mirogabalin is a treatment option for patients with neuropathic pain; however, safety, tolerability, and pharmacokinetics (PK) data specifically for Chinese individuals are limited to a single-dose study. We aimed to assess these for both single- and multiple-dose mirogabalin in healthy Chinese participants. METHODS: In this randomized, double-blind, placebo-controlled, phase I study, 54 healthy Chinese men and women aged 18-45 years were randomly allocated to receive single- (5, 10, or 15 mg, daily) or multiple-dose (5 mg titrated to 15 mg, twice-daily, over 22 days) oral mirogabalin or placebo...
February 15, 2023: Advances in Therapy