[Translation] A randomized, open-label, two-dose, single-dose, four-cycle, two-sequence, completely repeated crossover bioequivalence study of mirabegron extended-release tablets in healthy subjects under fasting conditions
主要研究目的 :通过健康受试者在空腹状态下分别单次口服由武汉人福利康药业有限公司生产的米拉贝隆缓释片(50mg,受试制剂)与 Astellas Pharma Global Development Inc持证的米拉贝隆缓释片(商品名:Myrbetriq ®,50mg,参比制剂)进行人体相对生物利用度研究,评价受试制剂与参比制剂的生物等效性。 次要研究目的 :评价中国健康受试者单次空腹口服米拉贝隆缓释片受试制剂和参比制剂后的安全性。
[Translation] The main purpose of the study is to evaluate the bioequivalence of the test preparation and the reference preparation by taking a single oral dose of Mirabegron sustained-release tablets (50 mg, test preparation) produced by Wuhan Renfu Likang Pharmaceutical Co., Ltd. and Mirabegron sustained-release tablets (trade name: Myrbetriq ®, 50 mg, reference preparation) produced by Astellas Pharma Global Development Inc. in healthy subjects under fasting state. Secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of Mirabegron sustained-release tablets after a single oral dose in Chinese healthy subjects under fasting state.