[Translation] A single-center, randomized, open-label, fasting, single-dose, two-formulation, three-sequence, three-period, crossover bioequivalence study of fexofenadine hydrochloride oral suspension in healthy adult participants in China.
主要研究目的:
考察单次(空腹)口服30mg(5mL)受试制剂盐酸非索非那定口服混悬液(规格:120mL:0.72g,批号:Y2503020,海南斯达制药有限公司生产)与参比制剂盐酸非索非那定口服混悬液(商品名:Children's Allegra Allergy®,规格:30mg/5mL,批号:5CTA968,Sanofi-Aventis Deutschland GmbH生产)在中国健康成年参与者的相对生物利用度,分析两种制剂的药代动力学参数,评价两种制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价单次(空腹)口服30mg(5mL)受试制剂与参比制剂在中国健康成年参与者中的安全性。
[Translation] Primary Objective: To investigate the relative bioavailability of a single (fasting) oral dose of 30 mg (5 mL) fexofenadine hydrochloride oral suspension (specification: 120 mL: 0.72 g, batch number: Y2503020, manufactured by Hainan Star Pharmaceutical Co., Ltd.) and the reference formulation fexofenadine hydrochloride oral suspension (trade name: Children's Allegra Allergy®, specification: 30 mg/5 mL, batch number: 5CTA968, manufactured by Sanofi-Aventis Deutschland GmbH) in healthy adult participants in China. Pharmacokinetic parameters of the two formulations were analyzed, and their bioequivalence was evaluated, providing a reference for the drug's application and clinical use.
Secondary Objective: To evaluate the safety of a single (fasting) oral dose of 30 mg (5 mL) of the test formulation and the reference formulation in healthy adult participants in China.