[Translation] A single-center, randomized, open-label, two-drug trial of Compound Sulfamethoxazole Tablets from Harbin Pharmaceutical Group No. 6 Factory and Sun Pharmaceutical Industries Inc’s Compound Sulfamethoxazole Tablets (trade name: BACTRIM®) in Chinese healthy subjects , fasting, single-dose, two-period, double-crossover design bioequivalence study
以哈药集团制药六厂的复方磺胺甲噁唑片(400mg/80mg)为受试制剂,Sun Pharmaceutical Industries Inc上市的复方磺胺甲噁唑片(BACTRIM®,规格400mg/80mg)为参比制剂,考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性。
[Translation] Compound Sulfamethoxazole Tablets (400mg/80mg) from Harbin Pharmaceutical Group No. 6 Factory was used as the test preparation, and Compound Sulfamethoxazole Tablets (BACTRIM®, specification 400mg/80mg) listed by Sun Pharmaceutical Industries Inc was used as the reference preparation. Investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in a single administration in the fasting state, evaluate whether the two preparations have bioequivalence, and evaluate the safety of the two preparations in healthy subjects.