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Pharmacokinetics, Bioequivalence and Safety of Cloperastine in Chinese Healthy Subjects Under Fasting and Postprandial 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, Phase Clin Trial Ctr 1, Sch Pharm,Dept Pharm, Hengyang, 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, China
语种:
英文
期刊:
Drugs in R&D
ISSN:
1174-5886
年:
2022
卷:
22
期:
4
页码:
311-320
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]; Hunan Province Foundation of High-level Health Talent (225 Program); Changsha Central Hospital Affiliated to University of South China Foundation of key Program [YNKY202205]
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:
BACKGROUND: Cloperastine is a pivotal antibechic widely prescribed to treat cough caused by respiratory diseases. The present trial evaluated the pharmacokinetics (PK), bioequivalence (BE) and safety effects of the generic test (T) tablet of cloperastine after single-dose administration of cloperastine, compared with the original reference (R) tablet of cloperastine. OBJECTIVE: The purpose of this trial was to compare the PK, BE and safety of a test 10 mg versus the reference 10 mg formulation of cloperastine under fasting and postprandial cond...

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