Gallicano K, Sahai J
Bureau of Drug Research, Drugs Directorate, Health Canada, Ottawa, Ontario, Canada.
Br J Clin Pharmacol. 1996 Nov;42(5):632-4. doi: 10.1111/j.1365-2125.1996.tb00059.x.
The influence of gender on the single-dose pharmacokinetics of oral ciprofloxacin was investigated in a parallel designed study in 24 healthy, fasted volunteers. Ciprofloxacin (750 mg) was administered as a single tablet to 10 women and 14 men. All subjects were Caucasian except for one African American man. The mean age was 36 years for men and 33 years for women. Women received the drug during the nonmenstruating phase of their menstrual cycle and were not taking oral contraceptives at the time of the study. Plasma samples were collected over a 24 h period and assayed by h.p.l.c. The 90% confidence limits for the ratio of geometric means of maximum plasma concentration, apparent terminal half-life, and apparent oral plasma clearance (corrected for body weight) were between 80% and 125%, and those for the area under the plasma concentration-time curve were 71% and 101%. Results suggest that there were no gender-related differences in ciprofloxacin pharmacokinetics in men and nonmenstruating women of middle age.
在一项针对24名健康、空腹志愿者的平行设计研究中,考察了性别对口服环丙沙星单剂量药代动力学的影响。将环丙沙星(750毫克)制成单剂量片剂给予10名女性和14名男性。除1名非裔美国男性外,所有受试者均为白种人。男性平均年龄为36岁,女性为33岁。女性在月经周期的非月经期接受药物治疗,且在研究期间未服用口服避孕药。在24小时内采集血浆样本,并用高效液相色谱法进行分析。最大血浆浓度、表观终末半衰期和表观口服血浆清除率(经体重校正)几何均值之比的90%置信区间在80%至125%之间,血浆浓度-时间曲线下面积的90%置信区间在71%至101%之间。结果表明,中年男性和非月经期女性的环丙沙星药代动力学不存在与性别相关的差异。