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首页> 外文期刊>The journal of clinical psychiatry >Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study.
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Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study.

机译：西酞普兰和文拉法辛的品牌和通用制剂的药代动力学概况比较：一项交叉研究。

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BACKGROUND: Generic drugs are lower-cost versions of patent-expired brand-name medications. Bioequivalence is decreed when the 90% confidence intervals for the ratios of the generic to the reference compound for the area under the curve and maximum plasma concentration (C(max)) fall within a 0.80 to 1.25 range. The aim of the present pilot study was to compare the pharmacokinetic profiles of brand-name and generic formulations of citalopram and extended-release venlafaxine. METHOD: Effexor XR/Novo-venlafaxine XR 75 mg and Celexa/Gen-citalopram 40 mg were studied in a randomized crossover design. Healthy male volunteers took either Effexor XR or Novo-venlafaxine XR for 4 days, a 4-day washout was allowed, and then participants took the other venlafaxine formulation for 4 days. This was followed by a washout of at least 7 days. The participants then took Celexa or Gen-citalopram for 8 days, a 14-day washout was allowed, and then participants took the other citalopram formulation for 8 days. In each of the study phases, the sequence of treatment (brand-name x generic) was randomly assigned. Plasma levels of drugs were measured at fixed intervals after participants took the drugs and at steady state. The study was conducted from November 2007 through July 2008. RESULTS: Twelve participants completed the venlafaxine study. Nine of the participants, plus 3 new participants, were then enrolled in the citalopram study, to maintain a total of 12. The plasma levels of citalopram were similar after ingestion of the brand-name and generic drugs. After ingestion of venlafaxine, the C(max) values were 36 +/- 6 ng/mL and 52 +/- 8 ng/mL in the brand-name and generic groups, respectively. The ratio of the log-transformed values of C(max) was 150% and, therefore, not within the acceptable 80% to 125% range. The concentration of the active metabolite of venlafaxine (O-desmethyl-venlafaxine [ODV]) was also significantly increased in the generic group (+43% higher in the generic group at 3 h; +48% higher at 5 h; p < .05). No differences were seen at steady state for either ODV or venlafaxine. Participants taking Novo-venlafaxine reported 3 times more side effects than those taking Effexor XR. Pill contents were identical in the 2 groups, but extraction of venlafaxine occurred more readily with the generic formulation than with the brand-name formulation, which required an additional sonication. CONCLUSION: Gen-citalopram appeared to be bioequivalent to Celexa, whereas Novo-venlafaxine XR was not bioequivalent to Effexor XR. Consequently, the Novo-venlafaxine formulation released its active ingredient more rapidly and outside the acceptable norm. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00676039.
机译：背景：仿制药是专利过期品牌药的低成本版本。当曲线下面积和最大血浆浓度（C（max））的通用化合物与参考化合物之比的90％置信区间落在0.80至1.25范围内时，生物等效性降低。本试验研究的目的是比较西酞普兰和缓释文拉法辛的品牌和通用配方的药代动力学特征。方法：采用随机交叉设计研究了Effexor XR / Novo-文拉法辛XR 75 mg和Celexa / Gen-西酞普兰40 mg。健康的男性志愿者服用Effexor XR或Novo-文拉法辛XR持续4天，允许冲洗4天，然后参与者服用另一种文拉法辛制剂4天。随后至少冲洗7天。然后，参与者服用Celexa或Gen-citalopram 8天，允许冲洗14天，然后参与者服用另一种西酞普兰制剂8天。在每个研究阶段，都随机分配治疗顺序（品牌名称x通用名称）。在参与者服用药物后的固定时间间隔和稳态下测量药物血浆水平。该研究于2007年11月至2008年7月进行。结果：十二名参与者完成了文拉法辛研究。然后有9名参与者和3名新参与者参加了西酞普兰研究，以维持总数12的水平。摄入名牌药和非专利药后，西酞普兰的血浆水平相似。摄入文拉法辛后，商品名和通用名组的C（max）值分别为36 +/- 6 ng / mL和52 +/- 8 ng / mL。 C（max）的对数变换值的比率为150％，因此不在可接受的80％至125％的范围内。文拉法辛的活性代谢产物（O-去甲基-文拉法辛[ODV]）的浓度也显着增加（普通组在3小时时增加+ 43％; 5小时时增加48％; p <。）。 05）。 ODV或文拉法辛在稳态下均未见差异。服用诺和文拉法辛的参与者的副作用比服用Effexor XR的参与者高3倍。两组中的药丸含量相同，但是使用通用制剂比使用品牌制剂更容易进行文拉法辛的提取，这需要额外的超声处理。结论：西酞普兰似乎与Celexa生物等效，而Novo-文拉法辛XR与Effexor XR生物等效。因此，Novo-文拉法辛制剂更快地释放了其活性成分，并且超出了可接受的标准。试验注册：clinicaltrials.gov标识符：NCT00676039。

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