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|Title: ||Bioequivalence evaluation of two brands of cefuroxime 500 mg tablets (cefuzime and zinnat) in healthy human volunteers|
|Authors: ||Al-Said, Mansour S.|
Al-Khamis, Khalil I.
Niazy, Esmail M.
El-Sayed, Yousry M.
Al-Rashood, Khalid A.
Al-Yamani, Mohd A.
Al-Najjar, Tawfeeq A.
Alam, Syed M.
Qumaruzaman, Q. Zaman
|Keywords: ||Bioequivalence evaluation|
Cefuzime and Zinnat
|Issue Date: ||2000 |
|Publisher: ||John Wiley & Sons|
|Citation: ||Biopharm Drug Dispos: 21, 205–210 (2000)|
|Abstract: ||A bio equivalence 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
AUC0 t, AUC0 8, Cmax, Tmax, T1:2 and Kel were determined from plasma concentrations of both
formulations and found to be in good agreement with reported values. AUC0 t, AUC0 8 and Cmax
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.|
|Appears in Collections:||College of Pharmacy|
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