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題 名 | Bioequivalence Assessment of Two Simvastatin Tablets in Healthy Taiwanese Volunteers=兩種不同處方錠劑Simvastatin於臺灣受試者之生體相等性研究 |
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作 者 | 曾智盟; 黃淳真; 何孟漘; 陳彥安; 謝瀛華; 陳一愷; | 書刊名 | 藥物食品分析 |
卷 期 | 15:1 2007.03[民96.03] |
頁 次 | 頁15-19+94 |
分類號 | 418.1 |
關鍵詞 | 生體相等性; 藥物動態學; Simvastatin; β-hydroxyacid simvastatin; Bioequivalence; Pharmacokinetics; |
語 文 | 英文(English) |
中文摘要 | 本研究旨在評估兩種simvastatin錠劑(Zolotin及ZOCOR®)於26位台灣男性健康受試者之生體相等性研究。利用隨機,二個次序,二週期,交叉之試驗設計方式單劑量口服投與simvastatin錠劑。分別於投藥前及投藥後第0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14及24 hr收集血液檢品,透過液相層析串聯質譜儀(LC/MS/MS)分析其中β-hydroxyacid simvastatin之濃度。以非房室模式分析藥物學參數,且經用對數轉換過之AUC0-t,AUC0-∞及Cmax作變異數分析。Zolotin與ZOCOR®的Cmax分別為4.78 ± 2.75及4.52 ± 2.01 ng/mL,Tmax為3.80 ± 1.63及4.31 ± 1.73 hr,T1/2為4.32 ± 1.82及5.11 ± 2.49 hr,AUC0-t 為35.6 ± 21.7及36.5 ± 20.0 ng×hr/mL,AUC0-∞為38.1 ± 24.3及40.3 ± 23.6 ng×hr/mL。二種錠劑之血中β-hydroxyacid simvastatin之1n(AUC0-t),1n(AUC0-∞)及1n(Cmax) 的90%均在可信賴度區間介於80-125%間,符合生體相等性規範。根據以上結果,可證明此學名藥品 Zolotin和ZOCOR®具生體相等性。 |
英文摘要 | The pharmacokinetics and bioequivalence of two tablets of simvastatin, Zolotin and ZOCOR®, were evaluated in 26 healthy male Taiwanese volunteers who reside in Taiwan. The experiments were designed as a randomized, two-sequence, two-period and single-dose crossover study. Blood samples were obtained at 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14 and 24 hr after oral dosing of one tablet. β-hydroxyacid simvastatin concentrations in plasma were analyzed by a validated LC/MS/MS method. The pharmacokinetic parameters were analyzed by non-compartmental analysis. The analysis of variance was carried out using log-transformed AUC0-t, AUC0-∞ and Cmax. The results revealed that the Cmax of Zolotin and ZOCOR® were 4.78 ± 2.75 ng/mL and 4.52 ± 2.01 ng/mL; the Tmax were 3.80 ± 1.63 hr and 4.31 ± 1.73 hr; the T1/2 were 4.32 ± 1.82 hr and 5.11 ± 2.49 hr; the AUC0-t were 35.6 ± 21.7 ng×hr/mL and 36.5 ± 20.0 ng×hr/mL; and the AUC0-∞ were 38.1 ± 24.3 ng×hr /mL and 40.3 ± 23.6 ng×hr/mL, respectively. The ratios of log-transformed AUC0-t, AUC0-∞, and Cmax values of the plasma β-hydroxyacid simvastatin between two tablets were within the range of 80-125% as judged by 90% confidence intervals and satisfied the bioequivalence criteria. The generic simvastatin tablets formulation, Zolotin, was shown to be bioequivalent to the ZOCOR® tablets. |
本系統中英文摘要資訊取自各篇刊載內容。