Delving into the Latest Updates on Frontida BioPharm Co., Ltd. with Synapse

Overview

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, Bilastine Tablets (strength: 20 mg), and the reference preparation, Bilastine Tablets (strength: 20 mg) in healthy adult participants under fasting conditions

主要研究目的：研究空腹状态下单次口服受试制剂比拉斯汀片（规格：20mg，郑州卓峰制药有限公司生产）与参比制剂比拉斯汀片（规格：20mg，A.Menarini Manufacturing Logistics andServices s.r1生产）在健康参与者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂比拉斯汀片（规格：20mg）和参比制剂比拉斯汀片（规格：20mg）在健康参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of a single oral dose of the test preparation Bilastine Tablets (Specification: 20 mg, produced by Zhengzhou Zhuofeng Pharmaceutical Co., Ltd.) and the reference preparation Bilastine Tablets (Specification: 20 mg, produced by A.Menarini Manufacturing Logistics and Services s.r1) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. The secondary purpose of the study is to evaluate the safety of the test preparation Bilastine Tablets (Specification: 20 mg) and the reference preparation Bilastine Tablets (Specification: 20 mg) in healthy participants.

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Frontida BioPharm Co., Ltd.

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