Bioequivalence Study of Ondansetron Tablet in Healthy Thai Male Volunteers
MANUPAT LOHITNAVY, M.Sc.*, ORNRAT LOHITNAVY,M.Sc.*, KASINEE CHAUITTIPRASERT, Pharm.D.* , PRAWIT TAYTIWAT,M.D.** SANGLAR POLNOK, M.N.s.***
Affiliation : "' Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, "'* Health Sciences Research Institute, ***Faculty of Nursing, Naresuan University, Phitsanulok 65000, Thailand.
Objectives : To assess the average bioequivalence of two formulations of 8-mg ondan setron tablets - test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome, USA) - in 14 healthy Thai male volunteers.
Materials and Methods : In a randomized, single dose, fasting, two-period, crossover study design with a 1-week washout period, each subject received an 8-mg ondansetron tablet. Serum samples were collected over a 24-hour period after administration. Subsequently serum concentrations of ondansetron were analyzed by using a validated HPLC-UV method. Pharmacokinetic parameters were determined by using non-compartmental analysis.
Results : No significant difference was observed in any of the pharrnacokinetic parameters analyzed. The time to reach the maximal concentration (T mu' hour), the peak concentration (Cmax' ng/ ml) and the area under the concentration-time curve (AUC ng.hlml) of ondansetron for reference _,0 and test preparations were 2.6 ± 1.8 vs 2.2 ± 0.6, 49.5 ± 18.9 vs 48.5 ± 13.7 and 352.2 ± 184.7 vs 323.8 ± 154.5, respectively. The 90 per cent confidence intervals for Test/Reference ratio of Cmax and AUC were found within the bioequivalence range of 80-125 per cent (90.3-llO.O% and 88.4- _0 99.6%, respectively).
Conclusion : The bioequivalence of these two ondansetron preparations was demonstrated.
Keywords : Bioequivalence, Ondansetron
