[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of phloroglucinol oral lyophilized tablets (80 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择Teva Sante为持证商的间苯三酚口服冻干片(商品名:Spasfon Lyoc,规格:80mg)为参比制剂,对北京星昊盈盛药业有限公司生产,南京艾德凯腾生物医药有限责任公司提供的受试制剂间苯三酚口服冻干片(规格:80mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂间苯三酚口服冻干片(规格:80mg)和参比制剂间苯三酚口服冻干片(商品名:Spasfon Lyoc,规格:80mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the oral lyophilized tablets of phloroglucinol (trade name: Spasfon Lyoc, specification: 80mg) of Teva Sante as the licensee were selected as the reference preparation, and the test preparation of oral lyophilized tablets of phloroglucinol (specification: 80mg) produced by Beijing Xinghao Yingsheng Pharmaceutical Co., Ltd. and provided by Nanjing Aidekaiteng Biomedicine Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purpose: To observe the safety of oral administration of the test preparation of oral lyophilized tablets of phloroglucinol (specification: 80mg) and the reference preparation of oral lyophilized tablets of phloroglucinol (trade name: Spasfon Lyoc, specification: 80mg) by healthy volunteers.