[Translation] A randomized, open-label, two-dose, two-sequence, single-dose, completely repeated crossover design bioequivalence study of lansoprazole enteric-coated capsules was conducted in healthy subjects under fasting and fed conditions.
主要目的:以石药集团中诺药业(石家庄)有限公司生产的兰索拉唑肠溶胶囊为受试制剂,以天津武田药品有限公司生产的兰索拉唑肠溶胶囊(商品名:达克普隆®)为参比制剂,按生物等效性试验的相关规定,比较兰索拉唑肠溶胶囊在健康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。 次要目的:评价健康受试者单次空腹/餐后口服兰索拉唑肠溶胶囊受试制剂和参比制剂后的安全性。
[Translation] The primary objective was to use Lansoprazole Enteric-coated Capsules produced by Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical Co., Ltd. as the test preparation and Lansoprazole Enteric-coated Capsules (trade name: Dakopron®) produced by Tianjin Takeda Pharmaceutical Co., Ltd. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of Lansoprazole Enteric-coated Capsules in healthy subjects was compared to evaluate the bioequivalence of the two preparations. The secondary objective was to evaluate the safety of the test preparation and the reference preparation of Lansoprazole Enteric-coated Capsules after a single oral administration on an empty stomach or after a meal in healthy subjects.