Pharmacokinetics of nifedipine in Taiwanese

Shu-Chen Chien, Yow Shieng Uang, Hsiu Yi Lin, Kuang Yang Hsu

研究成果: 雜誌貢獻文章同行評審

9 引文 斯高帕斯(Scopus)

摘要

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® capsule as a reference drug after overnight fasting. Pharmacokinetic parameters derived from Adalat® 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 Cmax 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 Tmax was 0.61 h. Compared with other published studies, the Cmax 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.

原文英語
頁(從 - 到)77-84
頁數8
期刊Biopharmaceutics and Drug Disposition
25
發行號2
DOIs
出版狀態已發佈 - 3月 2004

ASJC Scopus subject areas

  • 藥學(醫學)
  • 藥理學、毒理學和藥劑學 (全部)

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