Bioequivalence evaluation of norfloxacin 400 mg tablets (Uroxin® and Noroxin®) in healthy human volunteers
✍ Scribed by Khalid A. Al-rashood; Khalil I. Al-khamis; Yoursy M. El-sayed; Sulaiman Al-bella; Mohd A. Al-yamani; S. Mahmood Alam; Ruwayda Dham
- Publisher
- John Wiley and Sons
- Year
- 2000
- Tongue
- English
- Weight
- 114 KB
- Volume
- 21
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
✦ Synopsis
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 AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and K(el) were determined from plasma concentrations for both the formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity), and C(max) 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.
📜 SIMILAR VOLUMES
A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of gliclazide 80 mg tablets, Glyzide (Julphar, UAE) as test and Diamicron (Servier Industries, France) as reference product. The study was performed at the International