Peck R W, Wootton R, Wiggs R, Layton G, Posner J
Glaxo Wellcome R & D Ltd, Greenford, Middlesex.
Br J Clin Pharmacol. 1998 Jul;46(1):83-6. doi: 10.1046/j.1365-2125.1998.00047.x.
The potential effects of food and gender on the pharmacokinetics of tucaresol were investigated in healthy volunteers.
Ten males (mean weight 76.5 kg, age 27-42 years) and eight females (mean weight 58.9 kg, age 18-44 years) received a single oral dose of 200 mg tucaresol on two occasions in random order. On one occasion, tucaresol was given after an overnight fast and on the other, immediately after ingestion of a standard breakfast.
There were no significant differences in standard pharmacokinetic parameters between the two occasions but the rate of tucaresol absorption was faster after food intake. Female subjects had higher Cmax (ratio 1.25 with 95% CI 1.10-1.44) and AUC (ratio 1.25 with 95% CI 1.05-1.49) values than males but the differences were due to the higher body weights of the males; weight-adjusted apparent total clearance values (CL/F) were not different between genders (ratio 1.03 with 95% CI 0.87-1.21).
Food intake and gender have no significant effect on the exposure to orally administered tucaresol.
在健康志愿者中研究食物和性别对土卡索(tucaresol)药代动力学的潜在影响。
10名男性(平均体重76.5千克,年龄27 - 42岁)和8名女性(平均体重58.9千克,年龄18 - 44岁)以随机顺序接受两次单剂量口服200毫克土卡索。一次是在空腹过夜后给予土卡索,另一次是在摄入标准早餐后立即给予。
两次给药之间标准药代动力学参数无显著差异,但进食后土卡索的吸收速率更快。女性受试者的Cmax(比值1.25,95%可信区间1.10 - 1.44)和AUC(比值1.25,95%可信区间1.05 - 1.49)值高于男性,但差异是由于男性体重较高;体重校正后的表观总清除率值(CL/F)在性别之间无差异(比值1.03,95%可信区间0.87 - 1.21)。
食物摄入和性别对口服土卡索的暴露无显著影响。