Bioavailability and Bioequivalence of Ondansetron Orally Disintegrating Tablets and Conventional Tablets

Purpose To study the bioavailability and bioequivalence of Ondansetron orally disintergrating tablet (test formulation) and conventional tablet (reference formulation) . Methods Test or reference tablets 8 mg were given to 20 male health volunteers with a randomized two-way crossover design. The drug levels in plasma were assayed by HPLC. The pharmacokinetic parameters of the two tablets were calculated with the 3P97 software. Results Pharmacokinetic parameters of orally disintegrating tablet and conventional tablet were as following: Cmax(35.67±8.944) and (35.81±10.03)ng/mL,tmax(1.509±0.790 7) and (1.525±0.580 4)h,AUC0-∞(265.2±101.5) and (272.6±114.2)ng·h/mL, (AUC0-t(230.2±77.99) and (230. 7±83. 59 )ng·h/mL, respectively. The mean relative bioavailability of test product vs. reference was 102.0% . Analysis of variance and two one-sided t-test showed that there were no significant difference between the two formulations. Conclusions Two formulations were bioequivalent.