目的 以盐酸帕罗西汀片（赛乐特）为参比制剂，研究盐酸帕罗西汀薄膜衣片的人体相对生物利用度，以判断两种制剂是否具有生物等效性。方法 采用随机、开放、双周期交叉试验设计，24例男性健康受试者禁食过夜后空腹单剂量口服盐酸帕罗西汀制剂20 mg，液相色谱-串联质谱法( LC- MS /MS)测定血浆中帕罗西汀的浓度，应用DAS2.0软件计算有关药动学参数并评价两种制剂的生物等效性。结果 单剂量口服受试制剂和参比制剂的主要药动学参数ρ_max分别为 (5.102±2.955)和 (5.396±2.852) μg·L^-1；t_max分别为 (5.22±1.83 )和 (5.35±0.78)h； t_1/2分别为(11.76±2.91)和 (11.98±3.57) h ；AUC_{0~96 h}分别为 (118.1±90.2)和 (118.9±86.0) μg·h·L^-1，AUC_0-∞分别为(120.2±91.0)和(121.5±87.6) μg·h·L^-1。结论 受试制剂与参比制剂的人体相对生物利用度为(100.6±22.0)%，两种制剂具有生物等效性。

OBJECTIVE To evaluate the relative bioavailibility and bioequivalence of paroxetine hydrochloride film-coated tablets. METHODS In a randomized crossover study， 24 healthy Chinese male subjects received a single oral dose (20 mg) of either test or reference paroxetine hydrochloride tablets after an overnight fast. The plasma concentrations of paroxetine were determined by a validated LC-MS/MS method. The pharmacokinetic parameters， the relative bioavailability and bioequivalence of two formulations were evaluated by DAS 2.0 software. RESULTS After a single oral dose of 20 mg test or reference paroxetine tablets， the pharmacokinetic parameters of paroxetine were as follows： ρ_max (5.102±2.955) and (5.396±2.852) μg·L^-1； t_max (5.22±1.83) and (5.35±0.78) h ； t_{1 /2} (11.76±2.91) and (11.98±3.57) h； AUC_{0~96 h} (118.1±90.2) and (118.9±86.0) μg·h·L^-1； AUC_0-∞ (120.2±91.0) and (121.5±87.6) μg·h·L^-1， respectively. CONCLUSION The relative bioavailability of the test paroxetine hydrochloride film-coated tablets is (100.6±22.0)% . The two preparations are bioequivalent.