[Translation] A single-center, randomized, open-label, single-dose, two-cycle, double-crossover fasting bioequivalence trial of misoprostol tablets in healthy adult female subjects
以上海新华联制药有限公司生产的米索前列醇片(受试制剂, 0.2mg/片)为受试制剂,以PIRAMAL HEALTHCARE UK LIMITED公司生产的 米索前列醇片(参比制剂,商品名:Cytotec®,0.2mg/片)为参比制剂,按生物 等效性试验的相关规定,比较两种制剂在中国健康成年女性受试者体内的药代 动力学行为,评价两种制剂的生物等效性。
[Translation] Misoprostol tablets (test preparation, 0.2 mg/tablet) produced by Shanghai Xinhualian Pharmaceutical Co., Ltd. were used as the test preparation, and misoprostol tablets (reference preparation, trade name: Cytotec®, 0.2mg/tablet) is the reference preparation. According to the relevant regulations of the bioequivalence test, the pharmacokinetic behavior of the two preparations in healthy adult female subjects in China is compared, and the biological properties of the two preparations are evaluated. effectiveness.