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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/2977

Title: Bioequivalence evaluation of norfloxacin 400 mg tablets (uroxin and noroxin) in healthy human volunteers
Authors: Al-Rashood, Khalid A.
Al-Khamis, Khalil I.
El-Sayed, Yoursy M.
Al-Bella, Sulaiman
Al-Yamani, Mohd A.
Alam, S. Mahmood
Dham, Ruwayda
Keywords: Bio Equivalence Evaluation
Human Volunteers
Issue Date: 2000
Publisher: John Wiley & Sons, Ltd.
Citation: Biopharmaceutics & Drug Disposition, 21: 175–179 (2000)
Abstract: A bioequivalence study of two oral formulations of 400 mg norfloxacin was carried out in 18 healthy volunteers according to a single dose, two-sequence, cross-over randomized design at College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, jointly with King Khalid University Hospital. The two formulations were: Uroxin® (Julphar, United Arab Emirates) as test and Noroxin® (Merck Sharpe & Dohme, BV, Netherlands). Both test and reference formulations were administered to each subject after an overnight fasting on 2 treatment days separated by 1 week wash-out period. After dosing, serial blood samples were collected for a period of 24 h. Plasma harvested from blood, was analysed for norfloxacin by a sensitive, reproducible and accurate HPLC method. Various pharmacokinetic parameters including AUC0–t, AUC0– , Cmax, Tmax, T1:2, and Kel were determined from plasma concentrations for both the formulations and found to be in good agreement with reported values. AUC0–t, AUC0– , and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval for test:reference ratio of these parameters were found within a bioequivalence acceptance range of 80–125%. Based on these statistical inferences, it was concluded that Uroxin is bioequivalent to Noroxin. Sons, Ltd.
URI: http://hdl.handle.net/123456789/2977
ISSN: 1099-081X
Appears in Collections:Faculty of Pharmacy Research Center

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