PHARMACOKINETIC AND RELATIVE BIOAVAILABILITY OF OFLOXACIN AFTER A SINGLE ORAL ADMINISTRATION IN CHINESE HEALTHY VOLUNTEERS

The bioavailability of domestic product of ofloxacin produced by Beijing Pharmaceutcal Fac-tory was studied in eight normal male volunteers. A single oral dose of 200 mg ofloxacin tablets made inChina or Japan was given according to a cross over design. Serum and urine levels of ofloxacin were measuredby both HPLC and bioassay. Pharmacokinetic parameters obtained from our studies showed no significant dif-ference either between the two products or between two assays. The concentration-time curves of the two products of ofloxacin measured by two assays all fitted to atwo-compartment open model. Cmax of ofloxacin (China) and Cmax of ofloxacin (Japan) measured bybioassay were 1.51±0.29 and 1.67±0.29 mg/l respectively; Tmax of the two products were 1.46 and 1.41h, respectively; AUC and t1/2β were 12.21±1.41 and 13.09±1.07 mg·h/l; 6.31 and 6.38 h,respectively. The relative bioavailabilities of ofloxacin made in China measured by HPLC and bioassay were 103 % and107% respectively.