[Translation] A single-center, randomized, open-label, two-period, two-crossover design to evaluate the human bioequivalence of a single oral dose of omeprazole enteric-coated capsules in healthy Chinese subjects
以健康志愿者为试验对象,采用随机自身交叉对照试验方法,以奥美拉唑肠溶胶囊(商品名:Losec®,规格:20 mg)为参比制剂,天津君安生物制药有限公司生产的奥美拉唑肠溶胶囊(规格:20 mg)为受试制剂,依据相关生物等效性试验规定,评估受试制剂、参比制剂作用于餐后状态下中国健康志愿者的生物等效性。
[Translation] Taking healthy volunteers as the test objects, a randomized self-cross-controlled trial method was used, and omeprazole enteric-coated capsules (trade name: Losec®, specification: 20 mg) were used as the reference preparation, produced by Tianjin Junan Bio-Pharmaceutical Co., Ltd. Omeprazole enteric-coated capsules (specification: 20 mg) are the test preparations. According to the relevant bioequivalence test regulations, the bioequivalence of the test preparations and reference preparations on Chinese healthy volunteers in the postprandial state is evaluated. .