| Summary: | Objective: To evaluate the bioequivalence of 24 mg betahistine dihydrochloride tablets between the test product (Stei®) and the reference product (Serc®) in healthy Thai volunteers.
Methods: This was an open-label, randomized sequence, single-dose, two-period crossover study in 24 healthy volunteers. Half of the volunteers received a single dose of test product 24 mg and then reference product 24 mg after a minimum 7-day washout period. The remaining half of volunteers received the reference product first and then the test product with the same washout period. Blood samples were obtained at pre-dose and over 14 hours after dosing. Plasma concentrations of 2-pyridylacetic acid (2-PAA), a major metabolite of betahistine were quantified by using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Tolerability in volunteers was assessed during the study.
Results: Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. The geometric mean ratios of 2-PAA between the test and reference products were 96.44%, 96.99%, and 94.56% for Cmax, AUC0-t, and AUC0-∞, respectively. These pharmacokinetic parameter values lie within the FDA and European Medicines Agency specified bioequivalence limit (80-125%). No serious adverse events related to the studied drugs were found.
Conclusion: It can be concluded that these two betahistine dihydrochloride products were considered bioequivalent.
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