一项旨在评价比拉斯汀20 mg和左西替利嗪5 mg每日一次治疗慢性特发性荨麻疹的疗效和安全性的双盲、双模拟、随机化、多中心、III期研究
[Translation] A double-blind, double-dummy, randomized, multicenter, phase III study to evaluate the efficacy and safety of bilastine 20 mg and levocetirizine 5 mg once daily in chronic idiopathic urticaria
本研究旨在确定比拉斯汀20 mg治疗CIU的疗效和安全性,并证明比拉斯汀的疗效与左西替利嗪5 mg相当。
[Translation] The aim of this study was to determine the efficacy and safety of bilastine 20 mg in the treatment of CIU and to demonstrate that bilastine was comparable in efficacy to levocetirizine 5 mg.
以健康成年人为对象的HTZ-312-2与AMD-2的生物等效性试验
[Translation] Bioequivalence study of HTZ-312-2 and AMD-2 in healthy adults
在中国健康受试者中评价单次、24小时给予久光制药株式会社生产的HTZ-312-2和日东电工株式会社生产的AMD-2,计算该情况下的药代动力学参数,并验证生物等效性。
[Translation] A single, 24-hour administration of HTZ-312-2 manufactured by Hisamitsu Pharmaceutical Co., Ltd. and AMD-2 manufactured by Nitto Denko Co., Ltd. was evaluated in healthy Chinese subjects, and the pharmacokinetic parameters in this case were calculated and verified. Bioequivalence.
在中国人群中不同剂量的比拉斯汀单次给药和多次给药药代动力学研究
[Translation] Single-dose and multiple-dose pharmacokinetics of bilastine at different doses in the Chinese population
本研究旨在评估中国健康受试者中不同剂量的比拉斯汀单次给药和多次给药的药代动力学(PK)。本研究的主要目的是确定中国健康人群中比拉斯汀口服给药的PK特征。本研究的次要目的是评估健康中国受试者中比拉斯汀单次给药和多次给药的安全性和耐受性。
[Translation] The aim of this study was to evaluate the pharmacokinetics (PK) of single- and multiple-dose bilastine at different doses in healthy Chinese subjects. The primary objective of this study was to determine the PK profile of bilastine administered orally in a healthy Chinese population. The secondary objective of this study was to evaluate the safety and tolerability of single- and multiple-dose bilastine in healthy Chinese subjects.
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