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Pharmacokinetics, Bioequivalence, and Safety of 2 Formulations of Hydroxychloroquine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions

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成果类型:
期刊论文
作者:
Luo, Hong-Yu;Long, Hui-Zhi;Zhou, Zi-Wei;Xu, Shuo-Guo;Li, Feng-Jiao;...
通讯作者:
Li-Chen Gao
作者机构:
[Long, Hui-Zhi; Cheng, Yan; Xu, Shuo-Guo; Wen, Dan-Dan; Deng, Ping; Luo, Hong-Yu; Gao, Li-Chen; Li, Feng-Jiao; Zhou, Zi-Wei] Univ South China, Changsha Cent Hosp, Sch Pharm, Dept Pharm,Phase I Clin Trial Ctr, Hengyang 421001, Hunan, Peoples R China.
通讯机构:
[Li-Chen Gao] S
School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, Hunan, China<&wdkj&>Corresponding Author:<&wdkj&>Li-Chen Gao, School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, Changsha Central Hospital Affiliated to University of South China, University of South China, Hengyang, Hunan, 421001, China
语种:
英文
关键词:
bioequivalence;fasting;fed;hydroxychloroquine;pharmacokinetic;safety
期刊:
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
ISSN:
2160-7648
年:
2023
卷:
12
期:
3
页码:
273-278
基金类别:
Science and Technology Key Program of Hunan Province [2016SK2066]; Hunan Province Chinese Medicine Research Program [201940]; Science and Technology Key Program of Hunan Provincial Health Committee [20201904]; Natural Science Foundation of Hunan Province [2021JJ30753]; Changsha Central Hospital; University of South China Foundation of key Program [YNKY202205]; Hunan Province Foundation of High-Level Health Talent (225 Program)
机构署名:
本校为第一机构
院系归属:
药学与生物科学学院
摘要:
The purpose of this trial was to evaluate the pharmacokinetics (PK), bioequivalence (BE), and safety of 2 preparations of hydroxychloroquine (200-mg tablet) under fasting and fed conditions. A total of 180 subjects (fasting condition: n = 80; fed condition: n = 100) were randomly enrolled in this randomized, open, single-dose, single-cycle parallel phase Ⅰ clinical study. Under the 2 conditions, the subjects were randomly administered the test (T) or reference (R) tablet, both at a dose of 200 mg (1 tablet). Liquid chromatography–tandem mass ...

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