Pharmacokinetics and bioequivalence studies of galantamine hydrobromide dispersible tablet in healthy male Chinese volunteers

A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0 -> t), (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0 ->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t(1/2) (elimination of half-life of the terminal log linear phase), C-max (maximum plasma drug concentration and T-max (time to reach C-max) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0 -> t) and AUC(0 ->infinity) were calculated by the linear-log trapezoidal rule method. C-max and T-max, were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0 -> t), AUC(0 ->infinity) and C-max. As far as AUC(0 -> t), AUC(0 ->infinity) and C-max were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(9 -> t), AUC(0 ->infinity) and C-max values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0 -> t), AUC(0 ->infinity) and C-max were entirely within 80-125%, two formulations were considered bioequivalent.