[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, repeated crossover, fasting and fed bioequivalence study of sulfasalazine oral suspension produced by Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. and sulfasalazine oral suspension licensed by Rosemont Pharmaceuticals Ltd in healthy Chinese subjects
评价上海信谊金朱药业有限公司生产的柳氮磺吡啶口服混悬液与Rosemont Pharmaceuticals Ltd持证的柳氮磺吡啶口服混悬液空腹及餐后单次口服给药在健康人群中的生物等效性。同时观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] To evaluate the bioequivalence of sulfasalazine oral suspension produced by Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. and sulfasalazine oral suspension certified by Rosemont Pharmaceuticals Ltd. in healthy subjects after single oral administration on an empty stomach or after a meal. At the same time, the safety of the test and reference preparations in healthy Chinese subjects was observed.