时间标签：数据日期 2026-10-31 · 生成时间 2026-11-01 05:30（Asia/Shanghai）｜ 检索窗口 PubMed edat 2026/10/28–2026/10/31 ｜ 情报发生日期 2026-10-31
研究问题
China bears one of the largest diabetes burdens worldwide, and type 2 diabetes mellitus (T2DM) remains a major public health challenge (; ).
方法
This was an open-label, randomized, single-dose, two-period, two-sequence crossover bioequivalence study conducted in healthy Chinese subjects under fasting and fed conditions, which is consistent with standard bioequivalence study design principles.；Subjects in the fasting and fed cohorts were randomized separately.；In each cohort, subjects were assigned in a 1:1 ratio to one of two treatment sequences (T–R or R–T), with a 5-day washout period between dosing periods.；In the fasting cohort, subjects received a single oral dose of the test or reference formulation with 240 mL of warm water after an overnight fast of at least 10 h.
核心结论
ANOVA results indicated no significant effects of sequence, period, or formulation on the ln-transformed pharmacokinetic parameters of sitagliptin under either fasting or fed conditions (all P > 0.05; ).；For metformin, a significant period effect was observed for AUC0–t and under fasting conditions (P < 0.05), whereas sequence and formulation effects were not significant.；No significant sequence, period, or formulation effects were observed under fed conditions (). ‖ 结论：These findings support the generic formulation as a therapeutically equivalent alternative to the reference product and provide evidence for its potential clinical use in the management of T2DM.
局限
Several limitations should be acknowledged.；Nevertheless, these limitations are inherent to most conventional bioequivalence studies and do not compromise the primary objective of establishing formulation equivalence.
对本项目的价值
★☆☆☆☆ 干预证据决定参照标准效应量——任何抗衰干预的收益至少应对标该基线。设计 open-label。
全文来源
PMC JATS 全文（正文 20,087 字符，已过标题/DOI 逐字归属校验）
原文题录
- 英文标题：Bioequivalence study of two formulations of a sitagliptin/metformin hydrochloride extended-release tablet in healthy Chinese subjects under fasting and fed conditions: a randomized, open-label, single-dose, crossover trial.
- 期刊与标识：Front Pharmacol · PMID 42952543 · DOI 10.3389/fphar.2026.1927547
A 级证据分级：A 级（同行评议人体研究）
本文属人体研究证据，但需注意：观察性或小样本干预的结论不等于已证实临床获益；效应量与长期安全性仍需更大规模、更长随访的试验验证。
关于本文的文献来源：本站依据 IMA 知识库「五刊监控·深度文献卡片」撰写，依据已获取的期刊全文（方法、样本量与结论已回到原文核对）；未能获取全文的同批条目另行标注「摘要级」，全程未做任何数值推算补全。