Francisco HARRISON*, M. Vedat EĞİLMEZ**°, Stephan de la MOTTE*, David EIERMAN*
*Harrisson Clinical Research, Albrechtstraße 43, 80337, Munich, GERMANY.
**Abdi Ibrahim Ilaç San. ve Tic. A.S. Kore Sehitleri Cad. No. 19, Zincirlikuyu, 80300, Istanbul, TURKEY.
°Correspondence

Summary:
This study was conducted as a single dose, open-label, randomised, two-period cross-over study in order to determine the bioequivalence of Oflocide?® 400mg fort tablet (Abdi Ibrahim Ilaç San. Ve Tic.A.S., Istanbul/Turkey) as compared to Tarivid® 400 mg tablet (Hoechst Marion Roussel, Bad Soden am Ts, Germany). This study was conducted at the Harrison Clinical ResearchGmbH, Munich Germany during 2000. The study included 16 healty volunteers and there was a wash-out period of 14 days between the phases. Blood samples were collected at t=0 and at 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3.5, 6, 9, 14, 24, 31, 38 and 48 hours. The oflaxxacin concentration in plasma was analysed by HPLC. Mean pharmacokinetic parameters for test and reference drugs were Cmax 6.00 and 5.86 (µg/mL), AUC last 32.90 and 32.90 (µg*h/mL), AUCinf 34.20 and 34.20 (µg*h/mL), tmax 1.13 and 1.00(h), t1/2 5.69 and 6.40 (h)respectively. Primary variables tested were Cmax 102% (90-117%), AUC last 100% (96-104%) AND AUC inf 100% (96-105%) within a confidence interval of 90%. Both test and reference drugs were well toleretad and the test product was found bioequivalent to the reference product.

Key words:
Ofloxacin, bioequivalence, HPLC, AUC, Cmax , tmax, t1/2