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

Q3 Pharmacology, Toxicology and Pharmaceutics

Fabad Journal of Pharmaceutical Sciences Pub Date : 2022-09-26 DOI:10.55262/fabadeczacilik.1103532

F. Yerlikaya, Aslıhan Arslan, Özlem Ati̇k, Seda Kozan, Ahmet Parlak, Meltem ÖZEL KARATAŞ, Onur Saglam, S. P. Aytaç

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引用次数: 0

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 (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 (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 The comparison study was performed as a single-center clinical study, and blood samples of the participants were withdrawn at specified time points, before and after dosing.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.

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两种头孢地尼制剂在健康男性禁食条件下的相对生物利用度研究

研制了头孢地尼口服制剂cefdinir 600 mg片剂，并将其与另一种已上市的口服固体剂型cefdinir 300 mg胶囊的相对生物利用度进行了比较。一项开放标签、随机、两期、交叉的相对生物利用度研究遵循良好临床实践(GCP)原则，在禁食条件下对健康男性进行。就其药代动力学性质而言，已将单剂量600毫克头孢地尼片剂制剂与两剂量300毫克头孢地尼胶囊(一次两粒胶囊)进行了比较。比较研究采用单中心临床研究，受试者在给药前后的指定时间点抽取血样。采用经验证的LC-MS/MS分析方法对两种头孢地尼制剂的血药浓度和药动学特性进行了评价。新配方的相对生物利用度已经被证明，两种产品都是安全的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Fabad Journal of Pharmaceutical Sciences Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

0.80

自引率

0.00%

发文量

期刊介绍： The FABAD Journal of Pharmaceutical Sciences is published triannually by the Society of Pharmaceutical Sciences of Ankara (FABAD). All expressions of opinion and statements of supposed facts appearing in articles and/or advertisiments carried in this journal are published on the responsibility of the author and/or advertiser, anda re not to be regarded those of the Society of Pharmaceutical Sciences of Ankara. The manuscript submitted to the Journal has the requirement of not being published previously and has not been submitted elsewhere. Manuscripts should be prepared in accordance with the requirements specified as given in detail in the section of “Information for Authors”. The submission of the manuscript to the Journal is not a condition for acceptance; articles are accepted or rejected on merit alone. All rights reserved.