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Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained-Release Capsule in Healthy Chinese Subjects

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成果类型:
期刊论文
作者:
Li, Xin*;Yuan, Fang;Xu, Bing;Xiao, Guiying;Fan, Xingming;...
通讯作者:
Li, Xin
作者机构:
[Xiao, Guiying; Li, Yuan; Tu, Shengqing; Yuan, Fang; Xu, Bing; Li, Xin; Zhang, Ping] Third Hosp Changsha, Dept Pharm, 176 Western Laodong Rd, Changsha 410015, Hunan, Peoples R China.
[Xiao, Guiying] Hunan Univ Tradit Chinese Med, Changsha, Hunan, Peoples R China.
[Fan, Xingming] Beijing Sihuan Pharmaceut Co Ltd, Beijing, Peoples R China.
通讯机构:
[Li, Xin] T
Third Hosp Changsha, Dept Pharm, 176 Western Laodong Rd, Changsha 410015, Hunan, Peoples R China.
语种:
英文
关键词:
bioequivalence;healthy Chinese subjects;pharmacokinetics;roxatidine;roxatidine acetate hydrochloride
期刊:
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
ISSN:
2160-7648
年:
2022
卷:
11
期:
5
页码:
597-605
基金类别:
We sincerely thank all the volunteers for participating in this clinical study. Furthermore, we sincerely thank Suzhou Guochen Biotek Co, Ltd. for their support in analyzing the samples.
机构署名:
本校为其他机构
摘要:
This study aimed to evaluate the bioequivalence between a generic roxatidine acetate hydrochloride (RAH) sustained-release capsule and brand-named formulation (ALTAT) under fasting and fed conditions. An open-label, single-center, randomized 2-period crossover study with a 5-day washout period was conducted. A single oral dose of 75-mg generic RAH sustained-release capsule (test drug) or a commercial capsule (reference drug) was given to healthy volunteers under fasting (n = 36) and fed conditions (n = 36). Blood samples were collected at basel...

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