Bioequivalence assessment of Azomycin (R) (Julphar, UEA) as compared with Zithromax (R) (Pfizer, USA) - Two brands of azithromycin - In healthy humanvolunteers

Two studies have been performed to assess the relative bioavailability of A zomycin (R) (Julphar, UAE) as compared with Zithromax (R) (Pfizer, USA) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved Azomycin (R) capsules and the other Azomycin (R) suspension . Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of azithromycin were administered as single dose o n two treatment days separated by a 2 weeks washout period. After dosing, s erial blood samples were collected for a period of 192 h. Plasma harvested from blood, was analysed for azithromycin by HPLC coupled with electrochemi cal detection. Various pharmacokinetic parameters including AUC(0-t), AUC(0 -x) C-max, T-max, T-1/2 and K-elm were determined from plasma concentration s for both formulations and found to be in good agreement with the reported values. AUC(0-t), AUC(0-x) and C-max were tested for bioequivalence after log-transformation of data. No significant difference was found based on AN OVA; 90% confidence intervals for the test/reference ratios of these parame ters were found within the bioequivalence acceptance range of 80-125%. Base d on these statistical inferences it was concluded that Azomycin (R) capsul e is bioequivalent to Zithromax (R) capsule and Azomycin (R) suspension is bioequivalent to Zithromax (R) suspension. Copyright (C) 2001 John Wiley & Sons, Ltd.