[Translation] A randomized, open-label, two-dose, single-dose, four-cycle crossover, fasting bioequivalence trial of Dantrolene Sodium Capsules in healthy Chinese subjects.
主要研究目的 评价武汉恒信源药业有限公司生产的受试制剂丹曲林钠胶囊(25mg/粒)与Par Formulations Private Limited生产的参比制剂Dantrolene sodium capsule(25mg/粒)(商品名:Dantrium)在空腹状态下的人体生物等效性。 次要研究目的 评价中国健康受试者单次空腹口服受试制剂丹曲林钠
[Translation] Main research purpose To evaluate the test preparation Dantrolene sodium capsule (25mg/capsule) produced by Wuhan Hengxinyuan Pharmaceutical Co., Ltd. and the reference preparation Dantrolene sodium capsule (25mg/capsule) produced by Par Formulations Private Limited (trade name: Dantrium) Human bioequivalence in the fasted state. Secondary research objectives To evaluate the single fasting oral administration of dantrolene sodium in healthy Chinese subjects