- 期刊
Bioequivalence Study of Two Clarithromycin Tablet Formulations in Taiwanese Males
Clarithromycin錠劑在台灣男性之生體相等性研究
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。
並列摘要
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.