Loi C M, Knowlton P W, Stern R, Randinitis E J, Vassos A B, Koup J R, Sedman A J
Department of Pharmacokinetics and Drug Metabolism, Parke-Davis Pharmaceutical Research Division, Ann Arbor, Michigan 48105, USA.
J Clin Pharmacol. 1998 Feb;38(2):178-83. doi: 10.1002/j.1552-4604.1998.tb04408.x.
Twelve healthy subjects participated in a study to determine the effect of multiple doses of troglitazone on the steady-state pharmacokinetics of digoxin. Subjects received digoxin 0.25 mg orally once daily on days 1 through 20 and 400 mg of troglitazone orally once daily on days 11 through 20. Serial plasma samples and 24-hour urine samples collected before and after the doses on days 10 and 20 were analyzed for digoxin using a radioimmunoassay method. Eleven subjects completed the study. Administration of multiple oral doses of digoxin and troglitazone was well tolerated. Mean values for maximum concentration (Cmax), time to Cmax (tmax), and area under the concentration-time curve from 0 to 24 hours (AUC0-24) of digoxin on day 10 were similar to those on day 20. Mean day 10 digoxin values for minimum concentration (Cmin), apparent oral clearance (Cl/F), total urinary excretion from 0 to 24 hours (Ae0-24), and renal clearance (Clr) were also similar to corresponding values on day 20. Thus, concomitant administration of multiple-dose troglitazone does not alter the steady-state pharmacokinetics of digoxin.
12名健康受试者参与了一项研究，以确定多次服用曲格列酮对地高辛稳态药代动力学的影响。受试者在第1天至第20天每天口服0.25mg地高辛，在第11天至第20天每天口服400mg曲格列酮。使用放射免疫分析法对第10天和第20天给药前后采集的系列血浆样本和24小时尿液样本进行地高辛分析。11名受试者完成了研究。多次口服地高辛和曲格列酮的耐受性良好。第10天地高辛的最大浓度（Cmax）、达峰时间（tmax）以及0至24小时浓度-时间曲线下面积（AUC0-24）的平均值与第20天相似。第10天地高辛的最小浓度（Cmin）、表观口服清除率（Cl/F）、0至24小时总尿排泄量（Ae0-24）以及肾清除率（Clr）的平均值也与第20天的相应值相似。因此，多次服用曲格列酮与地高辛同时给药不会改变地高辛的稳态药代动力学。
