Comparative bioavailability of cefuroxime axetil suspension formulations administered with food in healthy subjects

Mendes, Gustavo Duarte; Borges, André; Val, Ligia de Cássia; Patni, Anil; Reyar, Simrit; Monif, Tausif; Sereno, Daiene; Orellana, Ana Maria; Nucci, Gilberto De

doi:10.1055/s-0031-1296256

Arzneimittelforschung

2011

DOI: 10.1055/s-0031-1296256

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Comparative bioavailability of cefuroxime axetil suspension formulations administered with food in healthy subjects

Gustavo Duarte Mendes¹,

André Borges²,

Ligia de Cássia Val³

et al.

Abstract: Since the 90% CI for AUClast and Cmax ratios were within the 80-125% interval proposed by the US FDA, it was concluded that cefuroxime axetil (test formulation, 250 mg/5 mL suspension) was bioequivalent to a reference formulation under fed conditions, for both the rate and extent of absorption.

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Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

Al-Tamimi

Al-Mahroos

Al-Tamimi

et al. 2022

RJPT

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Cefuroxime axetil (CA) is a broad-spectrum second-generation cephalosporin antibiotic resistant to beta-lactamase used for treating different kinds of infections. This study was conducted to compare the pharmacokinetics (PK) and to evaluate the bioequivalence (BE) between a newly formulated generic CA 500mg tablets as a test formula with the same dose of the brand formula as the reference product applying 2-way, 2-treatment, 2-period, 2-sequence, randomized crossover design with six days washout interval between dosing. After overnight fasting for 12 hours, both CA products were administered to 28 healthy male adult Arabic subjects, followed by serial blood samples obtained from each subject before drug dosing (0-hr) and then up to 8 hours post-dosing. The calculated PK parameters Cmax, Tmax, AUC0–t, AUC0–∞, Thalf, MRT, Cl and Vd obtained from each product were statistically compared by ANOVA and 90% confidence interval tests to evaluate the BE between both products. Based on international guidance on bioequivalences like FDA and EMEA, it was concluded from this research that the test and the reference formulas are bioequivalent since the 90% confidence intervals were within the accepted ranges of 80.00-125.00%. All participants tolerated both products well, and they were discharged without any significant alterations in their clinical baseline characteristics. Therefore, the newly formulated generic CA 500mg tablets may be prescribed in clinical practice and used as a safe and effective alternative to the brand product.

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Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

Al-Tamimi

Al-Mahroos

Al-Tamimi

et al. 2022

RJPT

View full text Add to dashboard Cite

show abstract

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Comparative bioavailability of cefuroxime axetil suspension formulations administered with food in healthy subjects

Cited by 1 publication

References 6 publications

Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

Pharmacokinetic Comparison and Bioequivalence Evaluation between a Newly Formulated Generic and the Brand Cefuroxime Axetil Tablets in Healthy Male Adult Fasting Subjects

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