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Bioequivalence evaluation of two brands of cefuroxime 500 mg tablets (Cefuzime® and Zinnat®) in healthy human volunteers
Author(s) -
AlSaid Mansour S,
AlKhamis Khalil I,
Niazy Esmail M,
ElSayed Yousry M,
AlRashood Khalid A,
AlBella Sulaiman,
AlYamani Mohd A,
AlNajjar Tawfeeq A,
Alam Syed M,
Dham Ruwayda,
Zaman Qumaruzaman Q
Publication year - 2000
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.237
Subject(s) - bioequivalence , cmax , pharmacokinetics , medicine , confidence interval , cefuroxime , pharmacology , high performance liquid chromatography , dosing , bioavailability , chromatography , chemistry , antibiotics , biochemistry
A bioequivalence study of two oral formulations of 500 mg cefuroxime axetil was carried out in 24 healthy volunteers following a single dose, standard two‐treatment cross‐over design at the College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, working jointly with King Khalid University Hospital. The two formulations used were Cefuzime® (Julphar, United Arab Emirates) as the test and Zinnat® (Glaxo Wellcome, England) as the reference product. Both test and reference tablets were administered to each subject after an overnight fasting on two treatment days separated by a 1‐week washout period. After dosing, serial blood samples were collected for a period of 8 h. Plasma harvested from blood was analysed for cefuroxime by a sensitive, reproducible and accurate high pressure liquid chromatography (HPLC) method. Various pharmacokinetic parameters including AUC 0− t , AUC 0−∝ , C max , T max , T 1/2 and K el were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. AUC 0− t , AUC 0−∝ and C max were tested for bioequivalence after log‐transformation of data. No significant difference was found based on an analysis of variance (ANOVA); 90% confidence interval for test/reference ratio of these parameters were found within bioequivalence acceptance range of 80–125%. Based on these statistical inferences, it was concluded that Cefuzime® is bioequivalent to Zinnat®. Copyright © 2000 John Wiley & Sons, Ltd.