[Translation] Bioequivalence trial of diazepam rectal gel in Chinese healthy subjects in a single-center, randomized, open-label, two-drug, two-cycle, double-crossover fasted state
考察健康受试者在空腹状态下,单次给药10mg/2mL由江苏远恒药业有限公司生产的受试制剂地西泮直肠凝胶(规格:10mg/2mL)或由DPT LABORATORIES, LTD.生产的地西泮直肠凝胶(商品名:Diastat® AcudialTM,规格:10mg/2mL)的吸收程度和速度的差异,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] Investigate healthy subjects in the fasting state, a single dose of 10mg/2mL of the test preparation diazepam rectal gel (specification: 10mg/2mL) produced by Jiangsu Yuanheng Pharmaceutical Co., Ltd. or by DPT LABORATORIES, LTD. The difference in the absorption degree and speed of the produced diazepam rectal gel (trade name: Diastat® AcudialTM, specification: 10mg/2mL), the bioequivalence and safety between the two preparations were evaluated, and it was the registration application for the test preparation Provide evidence.