Bioequivalence study of two capsule formulations of omeprazole
Pillai, G.K.; Salem, M.S.; Najib, N.M.; Jilani, J.; Hasan, M.M.; Ghanem, E.; Sallam, E.; Shubair, M.S.; al-Delq, S.
Acta Pharmaceutica Hungarica 66(6): 231-235
1996
ISSN/ISBN: 0001-6659 PMID: 9604487 Document Number: 456429
Bioequivalency of Omeraz, a test-product of Arab Pharmaceutical Manufacturing Company (Jordan) and Losec, a reference product by Astra (Sweden), was evaluated by a randomised crossover study on 22 healthy male volunteers. Serum concentrations of omeprazole were measured by an HPLC assay. There were no statistically significant differences between the two products in terms of serum profile and pharmacokinetic parameters including AUC, Cmax, Tlag, Tmax, MRT, Ke and T1/2. The AUC ratios (Omeraz/Losec) for 24 hours and for infinity were respectively 1.02 with a 90% C.L. of 0.88-1.16 and 1.00 with a 90% C.L. of 0.88-1.14. The two products may be considered as bioequivalent in terms of the extent of absorption as indicated by the AUC ratios. However, the confidence limits of Cmax fall outside the FDA accepted range.