Bioequivalence Study of 2 Orodispersible Formulations of Ondansetron 8 mg in Healthy Volunteers

Abstract

This study was designed to compare the rate and extent of absorption of 2 oral formulations of ondansetron (CAS 99614-02-5) 8 mg orodispersible tablets in healthy volunteers. 22 subjects were administered ondansetron orodispersible tablets of test and reference formulation in a single-dose, 2-period, 2-sequence, fasting, open-label, crossover and randomised study. Plasma concentrations were determined by LC/MS/MS. Log-transformed AUCs and C_max values were tested for bioequivalence based on the ratios of the geometric means (test/reference). T_max was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC_0–t and C_max were within the bioequivalence acceptance range of 80–125%. According to the European Guideline [1] it may be therefore concluded that test formulation of ondansetron 8 mg orodispersible tablet is bioequivalent to the reference formulation.

Key words

antiemetic - bioequivalence - CAS 99614-02-5 - ondansetron - pharmacokinetics

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^* working at the institution at the time of the trial

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