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MechanismH1 receptor antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CA |
First Approval Date21 Apr 2016 |
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 the treatment of 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] This study aimed to determine the efficacy and safety of bilastine 20 mg in the treatment of CIU and to demonstrate that the efficacy of bilastine is comparable to that of 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] To evaluate the pharmacokinetic parameters of HTZ-312-2 produced by Hisamitsu Pharmaceutical Co., Ltd. and AMD-2 produced by Nitto Denko Corporation after a single, 24-hour administration in healthy Chinese subjects and to verify 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] Study on the pharmacokinetics of single and multiple doses of bilastine in 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] This study was designed to evaluate the pharmacokinetics (PK) of bilastine at different doses in healthy Chinese subjects after single and repeated administration. The primary objective of this study was to determine the PK characteristics of bilastine after oral administration in healthy Chinese subjects. The secondary objectives of this study were to evaluate the safety and tolerability of bilastine after single and repeated administration in healthy Chinese subjects.
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