Leucuta Sorin-Emilian *, Iuga Cristina *, Capalneanu Radu **, Popa Adina *, Preda Manuela *
University of Medicine and Pharmacy ,,luliu Hatieganu” Cluj-Napoca
* Prof. dr.Leucuta S.E.; Șef lucrări dr. C. Iuga; Șef lucr. dr. A. Popa; Șef lucr. dr. M. Preda: Faculty of Pharmacy, Bioequivalence laboratory
** Prof. dr. R. Capalneanu: Institute of Heart “N.Stancioiu” Cluj-Napoca
Abstract
The bioequivalence of two oral preparations of the omeprazole, the test preparation Omeran (Europharm, Brasov) and the reference product, Losee (Astra), both in a dose of 20 mg omeprazole, was assessed in an open, cross-over, randomized trial in 12 healthy male volunteers. A HPLC method with U.V. detection was used for the assessment of plasma omeprazole concentrations. The pharmacokinetic characteristics for omeprazole were determined from the plasma concentration-time data (Kinetica 3, Inna Phase). The tested product was bioequivalent with the reference product both as amount and rate of absorption; these products are interchangeable.