Bioequivalence evaluation of generic febuxostat versus Feburic® in healthy Chine...

연구 요약

Bioequivalence evaluation of generic febuxostat versus Feburic® in healthy Chinese subjects: a randomized crossover study.

BMC pharmacology & toxicology 학술지에 발표된 이 연구는 Wang F, Ye X, Li F 외 연구팀이 수행하였습니다.

이 연구는 'Bioequivalence evaluation of generic febuxostat versus Feburic® in healthy Chinese subjects: a randomized crossover study.'에 대한 과학적 분석을 제공합니다.

핵심 내용

PURPOSE: Febuxostat, a xanthine oxidase inhibitor, is a first-line treatment for gout with hyperuricemia. This study evaluated the pharmacokinetic (PK) bioequivalence, safety profile, and food effects of a generic febuxostat formulation compared to the reference product (Feburic®) in healthy Chinese volunteers PATIENTS AND METHODS: In this randomized, open-label, two-sequence, two-period crossover trial, 80 participants (74 males, 6 females) received single 40 mg doses of both test and reference formulations under fasting and fed conditions, separated by a 7-day washout. Plasma concentrations were quantified using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). Primary endpoints included peak plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last time quantifiable time point (AUC0-t), and area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), with bioequivalence determined using 90% confidence intervals (CIs) for geometric mean ratios (GMRs). RESULTS: All 90% CIs for GMRs fell within the 80-125% bioequivalence range (fasting: AUC0-t 99.08-104.28%, AUC0-∞ 98.73-103.84%, Cmax 92.87-112.14%; fed: AUC0-t 101.16-106.21%, AUC0-∞ 101.13-105.94%, Cmax 91.72-105.07%). High-fat meals delayed Tmax by 0.67 h and Tlag by 0.37 h (p < 0.05) while reducing systemic exposure (Cmax by ~ 35%, AUC0-∞ by ~ 12%; all p < 0.05). Adverse event incidence was 12.8% (fasting) and 25.0% (fed), with no serious adverse events reported. CONCLUSION: The generic febuxostat formulation demonstrated PK equivalence to Feburic® under both fasting and fed conditions, with comparable safety profiles. The observed food effects, while statistically significant, support flexible administration without meal restrictions, meeting pharmacokinetic criteria for consideration as a therapeutic alternative in gout management. CLINICAL TRIAL REGISTRATION: This study was prospectively registered (Registration No. CTR20233483; First Public Release Date: 1 November 2023) in the Chinese Clinical Trial Registration Platform ( http://www.chinadrugtrials.org.cn ), a registry recognized by the Chinese National Medical Products Administration (NMPA). The trial was conducted from 28 November 2023 to 26 December 2023.

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