Pharmacokinetics of Oral Prulifloxacin Capsules in Healthy Volunteers

The main objective of this paper is to investigate the pharmacokinetics of NM394 (an active metabolite of prulifloxacin) and evaluate the dose relationship and accumulation characteristics after single and multiple doses of prulifloxacin. Thirty healthy volunteers were given 132 mg, 264 mg, and 528 mg of prulifloxacin capsules in a randomized test corresponding to low, medium and high groups for single dose trial. With one-week washout period, 264 mg of prulifloxacin capsules were given to eight volunteers of the medium group for multiple doses trial. The concentration of NM394 in serum was determined by a sensitive HPLC method and its pharmacokinetic parameters were analyzed by DAS2.0.1 and evaluated by SPSS statistic software (version 13.0). Various parameters were determined. Numerical experiments show that the pharmacokinetic parameters of NM394 displayed first order linear pharmacokinetic character. There are no big differences in pharmacokinetic characteristics of NM394 between single and multiple doses. Almost no significant accumulation of drugs is observed after multiple doses of 264 mg per day for 7 d and chronopharmacokinetics were first observed.