[Translation] Bioequivalence study of fexofenadine hydrochloride oral suspension in Chinese healthy subjects in the fasting state with a randomized, open-label, single-dose, two-dose, three-sequence, three-period, partially repeated crossover design and in the fed state with a randomized, open-label, single-dose, two-dose, two-sequence, two-period crossover design.
主要目的:在中国健康受试者中评价哈尔滨葵花药业有限公司委托葵花药业集团重庆小葵花儿童制药有限公司生产的盐酸非索非那定口服混悬液(受试制剂,120ml:0.72g)与美国上市盐酸非索非那定口服混悬液(参比制剂,Children's Allegra® Allergy,30mg/5ml)的人体生物等效性。次要目的:观察盐酸非索非那定口服混悬液受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of fexofenadine hydrochloride oral suspension (test preparation, 120ml: 0.72g) produced by Chongqing Xiaokuihua Children's Pharmaceutical Co., Ltd. of Sunflower Pharmaceutical Group and commissioned by Harbin Sunflower Pharmaceutical Co., Ltd. with fexofenadine hydrochloride oral suspension (reference preparation, Children's Allegra® Allergy, 30mg/5ml) marketed in the United States in healthy Chinese subjects. Secondary objective: To observe the safety of the test preparation and reference preparation of fexofenadine hydrochloride oral suspension in healthy Chinese subjects.