[Translation] Randomized, open-label, two-formulation, single-dose, four-cycle, two-sequence, fully repeated cross-over fasting bioequivalence study of mirabegron extended-release tablets in healthy subjects
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] Main research purpose: Healthy subjects take a single oral dose of mirabegron sustained-release tablets (50 mg, test preparation) produced by Wuhan Renfulikang Pharmaceutical Co., Ltd. and licensed by Astellas Pharma Global Development Inc in a fasting state. A human relative bioavailability study was conducted on Mirabegron extended-release tablets (trade name: Myrbetriq®, 50 mg, reference preparation) to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary study objectives: To evaluate the safety of the test and reference preparations of mirabegron extended-release tablets after single fasting oral administration in Chinese healthy subjects.