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Gatifloxacin Pharmacokinetics in Healthy Men and Women

From the Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Purdue University, Indianapolis and West Lafayette, Indiana (Ms Zhang, Dr Overholser, Dr Kays, Dr Sowinski); Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana (Dr Overholser, Dr Kays, Dr Sowinski). Supported in part by grants from Bristol-Myers Squibb Company (Princeton, NJ) and by grant M01RR00750 from the National Institutes of Health (Bethesda, Md). Presented in part at the 106th Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics, Orlando, Florida.

The sex-based pharmacokinetics of gatifloxacin were investigated. Healthy subjects (6 men, 6 women) received a single oral dose of gatifloxacin 400 mg. Blood and urine samples were collected, and gatifloxacin concentrations were determined by high-performance liquid chromatography. Pharmacokinetic parameters were estimated by fitting appropriate models to the serum concentration-time data using ADAPT II. Linear regression analysis was used to determine the influence of sex and weight on the oral clearance (CL_s/F) and apparent steady-state volume of distribution (V_ss/F) of gatifloxacin. Women had a significantly smaller V_ss/F compared to men (93.5 ± 21.3 L vs 128.8 ± 16.2 L, P = .009); however, there was no significant difference when normalized for total body weight (TBW) or lean body weight (LBW). Neither CL_s/F nor peak serum concentration (C_max) was significantly different between sexes, although C_max was 25% higher in women (P = .06). Regression analyses revealed that TBW (R² = .63) and LBW (R² = .65) were strong predictors of V_ss/F. Given the smaller V_ss/F, women may have slightly higher maximum concentrations, but these differences are unlikely to have clinical significance.

Key Words: Oral pharmacokinetics • gatifloxacin • sex differences

Address for reprints: Kevin M. Sowinski, PharmD, Purdue University, Department of Pharmacy Practice, W7555 Myers Building, WHS, 1001 West 10th Street, Indianapolis, IN 46202; e-mail: ksowinsk{at}iupui.edu.