Pharmacokinetics of nifedipine in Taiwanese
Pharmacokinetics of nifedipine in Taiwanese
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DOI：
10.1002/bdd.386
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发表时间：
2004-03-01
影响因子：
2.1
通讯作者：
Hsu, KY
中科院分区：
文献类型：
--
作者：
Chien, SC;Uang, YS;Hsu, KY
为阐明硝苯地平在台湾的药代动力学，回顾性分析了过去5年在台湾完成的硝苯地平生物等效性研究。共有198名健康男性志愿者在禁食过夜后单次服用10 mg Adalat（R）胶囊作为参比药物。使用WinNonlin程序通过非房室分析计算Adalat（R）给药的药代动力学参数。台湾居民口服10 mg硝苯地平胶囊速释剂型后，观察到药代动力学参数呈偏态分布，无明显双峰证据。平均C-max为143.12 +/- 53.48 ng/ml，平均AUC为293.77 +/- 115.62 ng（.）h/ml，平均T-1/2为3.08 ± 1.61 h，Tmax中位数为0.61 h。与其他已发表的研究相比，台湾受试者服用10 mg硝苯地平后的C-max和AUC显著高于英国和美国受试者。然而，C-max和AUC与印度和墨西哥受试者相似。根据22.5 ng（.）根据Kleinbloesem提出的代谢速率为h/ml/mg的标准，69.7%的台湾人属于慢代谢型。根据本研究的结果，大多数台湾人的硝苯地平代谢活性较低。版权所有（C）2004约翰威利父子有限公司。
To elucidate the pharmacokinetics of nifedipine in Taiwanese, a retrospective review of nifedipine bioequivalence studies completed in Taiwan in the past 5 years was conducted. A total of 198 healthy male volunteers were given a single dose of a 10 mg Adalat(R) capsule as a reference drug after overnight fasting. Pharmacokinetic parameters derived from Adalat(R) administration were calculated by non-compartmental analysis with the WinNonlin program. After oral administration of an immediate-release dosage form of a 10 mg nifedipine capsule to Taiwan residents, a skewed distribution with no clear evidence of bimodality of pharmacokinetic parameters was observed. The mean C-max was 143.12 +/- 53.48 ng/ml, the mean AUC was 293.77 +/- 115.62 ng (.) h/ml, the mean T-1/2 was 3.08 +/- 1.61 h, and the median value of T-max was 0.61 h. Compared with other published studies, the C-max and AUC of nifedipine after 10 mg administration were significantly higher in Taiwanese than in British and American subjects. However, the C-max and AUC were similar to those of Indian and Mexican subjects. According to the antimode of AUC distribution of 22.5 ng (.) h/ml/mg proposed by Kleinbloesem, 69.7% of Taiwanese can be categorized as slow metabolizers. Based on the results in this study, the majority of Taiwanese show lower activity of nifedipine metabolism. Copyright (C) 2004 John Wiley Sons, Ltd.