[Translation] Human Bioequivalence Study of Bilastine Oral Solution
主要目的:本试验旨在研究健康受试者单次空腹口服深圳市贝美药业有限公司研制的比拉斯汀口服溶液(120 mL:0.3 g)的药代动力学特征;以 Faes Farma, S.A. 持证的比拉斯汀片(Bilaxten®,20 mg)为参比制剂,比较两制剂中药动学参数 Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This trial aims to study the pharmacokinetic characteristics of bilastine oral solution (120 mL: 0.3 g) developed by Shenzhen Beimei Pharmaceutical Co., Ltd. in healthy subjects after a single fasting oral administration; with Faes Farma, S.A.'s certified Bilaxten tablets (Bilaxten®, 20 mg) are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations are compared to evaluate the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects.
舒他西林干混悬剂在健康受试者中的单次给药、随机、开放、两周期、双交叉、餐后状态下的生物等效性研究
[Translation] Single-dose, randomized, open-label, two-period, double-crossover, bioequivalence study of sultacillin dry suspension in healthy subjects
主要研究目的:以PFIZER PHARMA PFE GmbH持证,Haupt Pharma Latina S.r.l. Latina生产的舒他西林干混悬剂(商品名:Unacid®;规格:375 mg/7.5 ml)为参比制剂,以成都锦华药业有限责任公司生产的舒他西林干混悬剂(规格:5.0 g/瓶)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the study: taking PFIZER PHARMA PFE GmbH licensed sultacillin dry suspension produced by Haupt Pharma Latina S.r.l. Latina (trade name: Unacid®; specification: 375 mg/7.5 ml) as the reference preparation, Chengdu Jinhua Sultacillin dry suspension (specification: 5.0 g/bottle) produced by Pharmaceutical Co., Ltd. is the test preparation, and the two drugs were evaluated through a single-center, randomized, open, single-administration, two-period, and double-crossover clinical study. Human bioequivalence of this preparation in the fed state.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
舒他西林干混悬剂在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] Bioequivalence study of sultacillin dry suspension in single administration, randomized, open, two-period, double-crossover, fasting and fed states in healthy subjects
主要研究目的:以PFIZER PHARMA PFE GmbH持证,Haupt Pharma Latina S.r.l. Latina生产的舒他西林干混悬剂(商品名:Unacid®;规格:375 mg/7.5 ml)为参比制剂,以成都锦华药业有限责任公司生产的舒他西林干混悬剂(规格:5.0 g/瓶)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purposes: Sultacillin dry suspension (trade name: Unacid®; specification: 375 mg/7.5 ml) produced by Haupt Pharma Latina S.r.l. Latina, licensed by PFIZER PHARMA PFE GmbH, was used as the reference preparation, and Chengdu Jinhua Sultacillin dry suspension (specification: 5.0 g/bottle) produced by Pharmaceutical Co., Ltd. is the test preparation, and the two drugs were evaluated through a single-center, randomized, open, single-dose, two-period, double-crossover clinical study. Human bioequivalence of this preparation in fasting and fed state.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
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