The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions

Abstract

A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice (GCP) principles. Two 250 mg/5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MS/MS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.