The Relative Bioavailability Study of Two Cefdinir Formulations in Healthy Males Under Fasting Conditions

Authors : Fırat YERLİKAYA, Aslihan ARSLAN, Özlem ATİK, Seda KOZAN, Ahmet PARLAK, Meltem ÖZEL KARATAŞ, Onursal SAĞLAM, Sevim Peri AYTAÇ

Pages : 25-36

Doi:10.55262/fabadeczacilik.1103532

View : 31 | Download : 25

Publication Date : 2023-03-01

Article Type : Research Paper

Abstract :A new oral formulation of cefdinir, Cefdinir 600 mg Tablets has been developed and in this study, its relative bioavailability has been compared with another oral solid dosage form, Cefdinir 300 mg Capsules, which is already on the market. An open-label, randomized, two-period, cross-over relative bioavailability study has been conducted with healthy males under fasting conditions in compliance with Good Clinical Practice insert ignore into journalissuearticles values(GCP); principles. A single dose of the novel tablet formulation of 600 mg cefdinir has been compared to two doses of Cefdinir 300 mg Capsules insert ignore into journalissuearticles values(two capsules at once); in terms of their pharmacokinetic properties. The comparison study was performed as a single-center clinical study, and blood samples of the participants were withdrawn at specified time points, before and after dosing. The plasma concentrations and pharmacokinetic properties of two cefdinir formulations were assessed from the collected samples by using a validated LC-MS/MS analytical method. The relative bioavailability of the new formulation has been shown and both products were introduced as safe.
Keywords : biyoyararlanım, sefdinir, sefalosporin, İKU