Bioequivalence Study of Two Empagliflozin Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

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成果类型：

期刊论文

作者：

Lei, Yuyan;Liu, Yuan;Gao, Lichen;Peng, Xueqiong;Chen, Lulu;...

通讯作者：

Li, XH

作者机构：

[Lei, Yuyan] Second Nanning People's Hosp, Phase Clin Study Lab 1, Nanning, Peoples R China.

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

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

[Gao, Lichen] Univ South China, Changsha Cent Hosp, PhaseIClin Study Ctr, Dept Pharm,Canc Inst, Changsha, Peoples R China.

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

通讯机构：

[Li, XH ] 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;empagliflozin;healthy subject;LC-MS/MS;pharmacokinetics

期刊：

Clinical Pharmacology in Drug Development

ISSN：

2160-763X

年：

2025

DOI：

10.1002/cpdd.1530

基金类别：

International Scientific and Technological Innovation Cooperation Base for Bioanalysis of Complex Matrix Samples

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：

Empagliflozin is a highly selective sodium-glucose cotransporter 2 inhibitor and an effective medication for treating diabetes. This study aimed to assess the pharmacokinetics and bioequivalence of two 10-mg empagliflozin tablets in healthy Chinese subjects and examine food's effect on absorption. The research was conducted as a single-center, randomized, open-label, single-dose, 2-way crossover study involving 47 subjects (fasting: n = 23, fed: n = 24). Subjects received either the test or reference drug and switched to the alternative after a 7-day washout period. Blood samples were collecte...

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Bioequivalence Study of Two Empagliflozin Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

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