Bioavailability and bioequivalency study of two formulations of ciprofloxacin tablet

ABSTRACT

The bioavailabiity and related pharmacokinetics of a single dose 500 mg tablet of ciprofloxacin as a test product [Ciprosam] and a reference [Tyflox] one were determined in 18 healthy male volunteers. The study was a randomized design with one-week wash out period between the doses. Ciprofloxacin concentration in the serum was determined by an HPLC method with UV detector. The mean pharmacokinetic parameters of the test and reference products were as follows t1/2abs [h] 0.89,0.57; ka [h-1] 0.844, 1.329; tl/2 el [h] 7.15, 6.90; kel [h-1] 115 0.100, 0.103; Cmax [micro g/ml] 0.82, 0.85; Tmax [h] 3.9, 1.7; MRT [h] 11.6, 10.7; AUC [micro g/ml.-h] 10.9, 9.6. The mean relative bioavailability of the test product was 114%. Both products were well tolerated by the patients without side effects. The serum profiles for ciprofloxacin in the test and reference products, the AUC and relative bioavailability, Cmax, MRT, kel and tlI2el indicated comparable bioavailabiity and related pharmacokinetics between the test and reference products