Fluoxetine 藥動學及兩種口服膠囊生體相等性研究   全文下載

Pharmacokinetics and Bioequivalent Study of Generic Fluoxetine Capsules Preparation

此試驗由二家不同藥廠所提供之Fluoxetine膠囊進行之藥物動力學及相對生體可用率試驗。Fluoxetine 20mg口服劑量每天2次重複給與13天於8位健康年輕男性進行之雙盲交叉試驗。給與每一劑量投藥間隔二星期。收集試驗前及試驗後適當時間之血液檢品直至72小時。藥物血漿濃度利用高效能液相層析儀進行分析。定量極限為5 ng／mL。同日間分析及異日間分析CV值均小於18%也證明此分析方法之準確度。計算穩定狀態之AUC, Cmax, Tmax，排除速率常數，半衰期值，並經統計學上之比較。發現無論變異數分析，power分析，90%信賴區間，and two one-sided tests結果，PROZAC和FLUOXETINE具生物相等性。"

The pharmacokinetics and relative bioavailability of fluoxetine capsules manufactured by two different pharmaceutical factories were carried out. A multiple oral doses ((20 mg/cap) × 2/day × 13 day)of fluoxetine was administered in 8 healthy young Chinese males in a completely double-blind cross-over design with a two week washout period between each dose. Plasma samples were obtained before (three minimum concentrations) and at various appropriate intervals after last dosing up to 72 hours. The plasma concentrations were then analyzed by a HPLC method. The limit of quantitation of this HPLC method was 5 ng/mL. The coefficients of variation of the within-day and between-day calibration curves (n = 6) range from 5 ng/mL to 500 ng/mL were less than 16 %, and the accuracy of this method was also verified. Values for the area under the plasma concentration-time curve at steady state (AUC), peak concentration (Cmax), time to peak concentration (Tmax), elimination rate constant, half-life, oral clearance were estimated and compared for each preparation. By ANOVA, power analysis, 90% confidence interval, and two one-sided tests, PROZAC and FLUOXETINE can be considered bioequivalent. 此試驗由二家不同藥廠所提供之Fluoxetine膠囊進行之藥物動力學及相對生體可用率試驗。Fluoxetine 20mg口服劑量每天2次重複給與13天於8位健康年輕男性進行之雙盲交叉試驗。給與每一劑量投藥間隔二星期。收集試驗前及試驗後適當時間之血液檢品直至72小時。藥物血漿濃度利用高效能液相層析儀進行分析。定量極限為5 ng／mL。同日間分析及異日間分析CV值均小於18%也證明此分析方法之準確度。計算穩定狀態之AUC, Cmax, Tmax，排除速率常數，半衰期值，並經統計學上之比較。發現無論變異數分析，power分析，90%信賴區間，and two one-sided tests結果，PROZAC和FLUOXETINE具生物相等性。