Bioequivalence study of ondansetron tablet in healthy Thai male volunteers.

Lohitnavy, Manupat; Chaijittiprasert, Kasinee; Polnok, Sanglar; Lohitnavy, Ornrat; Taytiwat, Prawit

Bioequivalence study of ondansetron tablet in healthy Thai male volunteers.

Date

2002-07-26

Authors

Lohitnavy, Manupat

Chaijittiprasert, Kasinee

Polnok, Sanglar

Lohitnavy, Ornrat

Taytiwat, Prawit

Abstract

OBJECTIVES: To assess the average bioequivalence of two formulations of 8-mg ondansetron tablets--test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome, USA)--in 14 healthy Thai male volunteers. MATERIAL AND METHOD: 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 pharmacokinetic parameters analyzed. The time to reach the maximal concentration (Tmax, hour), the peak concentration (Cmax, ng/ ml) and the area under the concentration-time curve (AUC(0-infinity), ng x h/ml) of ondansetron for reference 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(0-infinity) were found within the bioequivalence range of 80-125 per cent (90.3-110.0% and 88.4-99.6%, respectively). CONCLUSION: The bioequivalence of these two ondansetron preparations was demonstrated.

Description

Chotmaihet Thangphaet.

Citation

Lohitnavy M, Chaijittiprasert K, Polnok S, Lohitnavy O, Taytiwat P. Bioequivalence study of ondansetron tablet in healthy Thai male volunteers. Journal of the Medical Association of Thailand. 2002 Jul; 85(7): 808-13