Abstract

Mbang A. Owolabi*, Grace E. Ukpo, Martin E. Okenne, Olayinka O. Oyeniyi, Olajumoke O. Oladipo and Smith I. Jaja

The pharmacokinetic profile of levofloxacin in healthy black African subjects as well as the influence of gender on its pharmacokinetic parameters was investigated. Sixteen healthy adult volunteers (8 males and 8 females) enrolled in the study and took single oral dose of 500 mg levofloxacin (Levofloxï?? ) after informed consent. The blood of the volunteers was withdrawn from their antecubital vein at 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 and 36 h post dosing and analysed for levofloxacin concentration. The results of this study revealed that levofloxacin was well tolerated and detectable in the plasma seventeen min after dosing being faster in female than male. Bioavailability was not affected by gender and Tmax showed no significant difference between the genders (p 0.05). The Cmax and AUC0- were higher in the female than in the male subjects, plasma clearance (CL) was lower in female than in the male thus explaining the differences in the total systemic exposure of the drug. The volume of distribution (Vd) was significantly reduced in female compared to the male. When pharmacokinetics parameters were expressed relative to mg drug/total body weight or renal function, gender-related differences were attenuated. This result indicates that subject body weight or renal function may be involved in the pharmacokinetic differences of the subjects, thus drug administration based on sex is not relevant.