[Translation] Randomized, open-label, two-formulation, single-dose, two-cycle, crossed fasting and postprandial state bioequivalence trial of cycloserine capsules in healthy subjects
主要目的:以河北龙海药业有限公司生产的环丝氨酸胶囊(规格:250mg)为受试制剂,Meiji Seika ファルマ株式会社(日本明治)生产的环丝氨酸胶囊(规格:250mg)为参比制剂,比较中国健康受试者在空腹和餐后两种状态下单次口服环丝氨酸胶囊的体内血药浓度及主要药代动力学参数,评价两制剂的生物等效性。
次要目的:评价中国健康受试者在空腹和餐后两种状态下单次口服环丝氨酸胶囊受试制剂或参比制剂后的安全性。
[Translation] Main purpose: The cycloserine capsules (specification: 250mg) produced by Hebei Longhai Pharmaceutical Co., Ltd. are used as the test preparation, and the cycloserine capsules (specification: 250mg) produced by Meiji Seika Famous Co., Ltd. (Meiji, Japan) are used as the reference preparation. To compare the plasma concentration and main pharmacokinetic parameters of cycloserine capsules in Chinese healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of Chinese healthy subjects after a single oral administration of the test preparation or reference preparation of cycloserine capsules in both fasting and postprandial states.