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題名 | Bioequivalence Study of Two Clarithromycin Tablet Formulations in Taiwanese Males=Clarithromycin錠劑在臺灣男性之生體相等性研究 |
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作者 | 陳睿能; 陳怜均; 葉健全; 許明照; Chen, Ray-neng; Chen, Ling-chun; Yeh, Geng-chang; Sheu, Ming-thau; |
期刊 | 馬偕學報 |
出版日期 | 20120800 |
卷期 | 10 2012.08[民101.08] |
頁次 | 頁149-163 |
分類號 | 418.281 |
語文 | eng |
關鍵詞 | 電化學偵測器; 高效能液相層析儀; 生體相等性; Electrochemical detection; Clarithromycin; Bioequivalence; HPLC; |
中文摘要 | 目的:利用高效能液相層析儀搭配電化學偵測器,檢測兩種口服250毫克單一劑量的clarithromycin錠劑在健康台灣男性之生體相等性。材料與方法:共有12位健康男性受試者參與此單一劑量投與、連續兩期之雙向交叉試驗設計的臨床試驗。Clarithromycin之血中濃度是以確效後之高效液相層析分析法進行測試。口服兩種產品之血漿中藥物濃度計算出的藥物動力學參數:血漿藥物濃度對時間曲線下面積,包括由零時間到最後採血點(AUC0-last)及到無限大時間(AUC0-inf)的曲線下面積和最高血中濃度(Cmax)均以SAS一般線性模型程式計算分析,並以二次單邊t檢定和90%信賴區間方法分析藥物動力學參數間之差別。結果:本分析方法之同日間與異日間精密度均低於10%,然而準確度落在13%的標稱濃度之間。此外,定量極限可以達到20 ng/mL。經由統計結果發現,此兩種處方的三個藥物動力學參數AUC0-last,AUC0-inf,and Cmax之間並沒有顯著的差異,且其90%信賴區間91.86%-111.23%,90.23%-111.51%和88.92%-114.32%亦符合衛生署的規定。結論:試驗結果顯示,兩種clarithromycin錠劑以口服投與250毫克時,具有生體相等性。 |
英文摘要 | Objective: Examination of the bioequivalence of two clarithromycin tablet formulations with a 250-mg dose utilizing an improved HPLC method which employs a phenyl column with electrochemical detection. Materials and Methods: Twelve healthy Taiwanese male volunteers were recruited to participate in a single-dose, two-period, two-sequence, two-treatment crossover study. Clarithromycin plasma concentrations were monitored using a validated HPLC method. The normal pivotal parameters, AUC0-last, AUC0-inf, and Cmax, were calculated and compared using the SAS General Linear Model computer program. Two one-sided t distribution tests were also performed, as well as the 90% confidence interval method, to analyze mean differences of the three pivotal parameters. Results: The precision for interday and intraday runs were both under 10%, while their accuracies (standard error of the mean, SEM) were within 13% of the nominal concentration. Additionally, the lower limit of quantification was 20 ng/mL. Values of AUC0-last, AUC0-inf, and Cmax between these two formulations showed no significant differences, and the 90% confidence intervals were 91.86%-111.23%, 90.23%-111.51%, and 88.92%-114.32%, respectively, which meets the criteria proposed by the Department of Health, Taiwan. Conclusions: The results demonstrate that these two clarithromycin tablet products are bioequivalent when orally administered in a single 250-mg dose. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。