[Translation] A randomized, open-label, two-dose, crossover bioequivalence study of phloroglucinol orodisintegrating tablets (80 mg) in Chinese healthy subjects under fasting and fed conditions
研究健康受试者在空腹及餐后条件下,单次口服由南京羚诺生物医药技术研究院有限公司提供的间苯三酚口崩片(受试制剂T,规格:80mg)与相同条件下单次口服由Teva Sante持证的间苯三酚口崩片(参比制剂R,规格:80mg)的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] To study the pharmacokinetic characteristics of a single oral administration of phloroglucinol orodisintegrating tablets (test preparation T, specification: 80 mg) provided by Nanjing Lingnuo Biomedical Technology Research Institute Co., Ltd. to healthy subjects under fasting and postprandial conditions and a single oral administration of phloroglucinol orodisintegrating tablets (reference preparation R, specification: 80 mg) certified by Teva Sante under the same conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.