Comparative Pharmacokinetics and Bioequivalence of Two Sodium Valproate Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

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成果类型：

期刊论文

作者：

Liu, Yuan;Peng, Xueqiong;Zhao, Mengfei;Liu, Fengzhi;Wang, Xintong;...

通讯作者：

Lei, YY

作者机构：

[Liu, Yuan; Xu, Junmei] Cent South Univ, Xiangya Hosp 2, Dept Anesthesiol, Changsha, Peoples R China.

[Peng, Xueqiong] Univ South China, Inst Pharm & Pharmacol, Hengyang, Peoples R China.

[Li, Xiaohui; Lei, Yuyan; Zhao, Mengfei] Cent South Univ, Xiangya Sch Pharmaceut Sci, Dept Pharmacol, 172 Tongzipo Rd, Changsha 410000, Hunan, Peoples R China.

[Li, Xiaohui; Liu, Fengzhi; Zhou, Ling; Chen, Lulu; Chen, Weiming; Ouyang, Dongsheng; Wang, Xintong; Fang, Qing] Changsha Duxact Biotech Co Ltd, Changsha, Peoples R China.

[Li, Xiaohui; Liu, Fengzhi; Zhou, Ling; Chen, Lulu; Chen, Weiming; Ouyang, Dongsheng; Wang, Xintong; Fang, Qing] Hunan Key Lab Bioanal Complex Matrix Samples, Changsha, Peoples R China.

通讯机构：

[Lei, YY ] C

Cent South Univ, Xiangya Sch Pharmaceut Sci, Dept Pharmacol, 172 Tongzipo Rd, Changsha 410000, Hunan, Peoples R China.

语种：

英文

关键词：

bioequivalence;healthy subject;liquid chromatography–tandem mass spectrometry;pharmacokinetics;sodium valproate

期刊：

Clinical Pharmacology in Drug Development

ISSN：

2160-763X

年：

2025

卷：

期：

页码：

728-734

DOI：

10.1002/cpdd.1563

基金类别：

Hunan Science and Technology Youth Talent Support Program [2023TJ-N20]; Science and technology innovation program of Hunan Province [2023RC3232]

机构署名：

本校为其他机构

院系归属：

药学与生物科学学院

摘要：

Sodium valproate, a broad-spectrum antiseizure medication of the fatty acid derivative class, was investigated in this study. The trial was designed as a single-center, open-label, randomized, 2-treatment, 4-period, 2-sequence crossover study conducted among healthy Chinese subjects. The objective was to evaluate the pharmacokinetic properties and bioequivalence of a novel generic 0.2g sodium valproate tablet and the branded reference product under fasting (n = 28) and fed (n = 28) conditions, with a 14-day washout period between dosing periods. Blood samples were collected at predefined time ...

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Comparative Pharmacokinetics and Bioequivalence of Two Sodium Valproate Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

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