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Pharmacokinetics and Bioequivalence of 2 Products of Fluticasone Propionate Nasal Spray in Healthy Chinese Subjects

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成果类型:
期刊论文
作者:
Wang, Pengkai;Li, Yuan;Xu, Bing;Zhang, Ping;Cui, Chang;...
通讯作者:
Li, X
作者机构:
[Wang, Pengkai] Hunan Univ Chinese Med, Grad Sch, Changsha, Hunan, Peoples R China.
[Li, Yuan; Wang, Pengkai; Xu, Bing; Zhang, Ping; Li, Xin] Third Hosp Changsha, Dept Pharm, Changsha, Hunan, Peoples R China.
[Cui, Chang] Shanghai Omni Pharmaceut Co Ltd, Shanghai, Peoples R China.
[Li, Xin] Third Hosp Changsha, 176 Western Laodong Rd, Changsha 410015, Hunan, Peoples R China.
通讯机构:
[Li, X ] T
Third Hosp Changsha, 176 Western Laodong Rd, Changsha 410015, Hunan, Peoples R China.
语种:
英文
关键词:
allergic rhinitis;bioequivalence;fluticasone propionate;nasal spray;pharmacokinetics;safety
期刊:
Clinical Pharmacology in Drug Development
ISSN:
2160-763X
年:
2025
卷:
14
期:
5
页码:
398-403
基金类别:
Shanghai Omni Pharmaceutical Co., Ltd.
机构署名:
本校为第一机构
院系归属:
研究生院
摘要:
Fluticasone propionate nasal spray is widely regarded as a first-line therapy for allergic rhinitis. To establish bioequivalence between the test and reference products of fluticasone propionate nasal spray, an open-label, randomized, single-dose, and 2-sequence crossover study was conducted on 84 healthy Chinese subjects under fasting conditions to determine the pharmacokinetic bioequivalence of the 2 products. Following a single-dose administration (200µg) of fluticasone propionate nasal spray, pharmacokinetic parameters, including maximum p...

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