Expert opinion on drug metabolism & toxicology · 2025
Bioequivalence and safety evaluation of betahistine hydrochloride tablets: a randomized, open - label, crossover study.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Pan Zhixiang, Liu Guan, Yao Fang, Yan Hegui, Cao Dan, Wang Qingqing, Peng Yu, Huang Tao, Wang Yiyi, Li Linling, Wang Junchen, Li Yuehua
Аннотация
BACKGROUND: Betahistine hydrochloride is critical for Ménière's syndrome treatment. Validating bioequivalence of generic and reference formulations under fasting/postprandial conditions is key for clinical substitution.
RESEARCH DESIGN AND METHODS: Single-center, randomized, open-label, two-period crossover study; 26 healthy subjects per arm. Test (Tianfang) and reference (Mylan) 8 mg tablets were compared. Plasma 2-pyridineacetic acid quantified via UPLC-MS/MS. Safety monitored via adverse events, vital signs, and labs.
RESULTS: 90% CIs for Cmax/AUC0-t/AUC0-∞ (test/reference) were 80%-125%. Adverse events were mild (fasting: test 23.1%, reference 19.2%; postprandial: test 26.9%, reference 7.7%); no severe reactions.
CONCLUSIONS: Test formulation is bioequivalent and well-tolerated to reference, supporting interchangeability. Limitations: small single-center sample, healthy subjects.
RESEARCH DESIGN AND METHODS: Single-center, randomized, open-label, two-period crossover study; 26 healthy subjects per arm. Test (Tianfang) and reference (Mylan) 8 mg tablets were compared. Plasma 2-pyridineacetic acid quantified via UPLC-MS/MS. Safety monitored via adverse events, vital signs, and labs.
RESULTS: 90% CIs for Cmax/AUC0-t/AUC0-∞ (test/reference) were 80%-125%. Adverse events were mild (fasting: test 23.1%, reference 19.2%; postprandial: test 26.9%, reference 7.7%); no severe reactions.
CONCLUSIONS: Test formulation is bioequivalent and well-tolerated to reference, supporting interchangeability. Limitations: small single-center sample, healthy subjects.