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AbstractObjective: To determine the
Abstract
Objective: To determine the relative bioavailability of two nimesulide preparations commercially available in Italy [the original product Aulin® (test preparation) and a generic product Nimesulide Dorom (reference preparation)] following single oral administration to healthy volunteers, since in vitro investigation has shown that the dissolution of nimesulide from Aulin® is faster and more complete than from the generic product.
Design: Randomised, two-way, cross-over study.
Patients and Participants: 18 healthy male volunteers.
Methods: Blood samples were withdrawn up to 24 hours after administration of the two preparations, each containing 100mg of nimesulide, and the plasma concentrations of nimesulide and its main metabolite 4′-hydroxy-nimesulide were quantified using a validated high performance liquid chromatography analytical method with ultraviolet detection.
Results: For the area under the curve calculated from time zero to infinity (AUC0-∞), arithmetic mean values for nimesulide were 19.93 (test preparation) and 9.32 (reference preparation) mg·h/L. The corresponding values for the metabolite 4′-hydroxy-nimesulide were 11.95 and 5.59 mg·h/L, respectively. The mean peak nimesulide plasma concentrations (Cmax) [value for the metabolite in parentheses] were 4.67 (1.63) mg/L for the test preparation and 1.60 (0.65) mg/L for the reference preparation. In addition, for nimesulide the ratio Cmax/AUC0-∞ was calculated. The values obtained were 0.25h−1 (test) and 0.18h−1 (reference). Statistical comparisons of all three parameters (analysis of variance and confidence intervals) after logarithmic transformation showed significant differences and bioinequivalence between the test and reference preparations.
Conclusions: According to the results obtained in this study, the generic product Nimesulide Dorom cannot be regarded as comparable to the original product Aulin®, and consequently the two preparations cannot be considered interchangeable products according to the World Health Organization definition of generics.
Objective: To determine the relative bioavailability of two nimesulide preparations commercially available in Italy [the original product Aulin® (test preparation) and a generic product Nimesulide Dorom (reference preparation)] following single oral administration to healthy volunteers, since in vitro investigation has shown that the dissolution of nimesulide from Aulin® is faster and more complete than from the generic product.
Design: Randomised, two-way, cross-over study.
Patients and Participants: 18 healthy male volunteers.
Methods: Blood samples were withdrawn up to 24 hours after administration of the two preparations, each containing 100mg of nimesulide, and the plasma concentrations of nimesulide and its main metabolite 4′-hydroxy-nimesulide were quantified using a validated high performance liquid chromatography analytical method with ultraviolet detection.
Results: For the area under the curve calculated from time zero to infinity (AUC0-∞), arithmetic mean values for nimesulide were 19.93 (test preparation) and 9.32 (reference preparation) mg·h/L. The corresponding values for the metabolite 4′-hydroxy-nimesulide were 11.95 and 5.59 mg·h/L, respectively. The mean peak nimesulide plasma concentrations (Cmax) [value for the metabolite in parentheses] were 4.67 (1.63) mg/L for the test preparation and 1.60 (0.65) mg/L for the reference preparation. In addition, for nimesulide the ratio Cmax/AUC0-∞ was calculated. The values obtained were 0.25h−1 (test) and 0.18h−1 (reference). Statistical comparisons of all three parameters (analysis of variance and confidence intervals) after logarithmic transformation showed significant differences and bioinequivalence between the test and reference preparations.
Conclusions: According to the results obtained in this study, the generic product Nimesulide Dorom cannot be regarded as comparable to the original product Aulin®, and consequently the two preparations cannot be considered interchangeable products according to the World Health Organization definition of generics.
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摘要目的: 确定两种尼美舒利制剂的相对生物利用度商用在意大利 [原始产品 Aulin ® (备考) 和通用产品尼美舒利 Dorom (参比制剂)] 后单次口服健康志愿者，因为体外研究表明，尼美舒利从 Aulin ® 解散是更快、 更从通用产品的完整。设计: 随机、 双向、 交叉研究。病人和参与者: 18 健康男性志愿者。方法: 血液样本被撤回到两种制剂，每个含有 100 毫克的尼美舒利，给药后的 24 小时，血浆浓度的尼美舒利和其主要代谢产物 4 ′-羟基-尼美舒利进行量化使用经过验证的高性能液相色谱法分析方法，利用紫外检测。结果: 从时间为零到无穷大 (AUC0-∞) 计算曲线下面积，尼美舒利的算术平均值值是 19.93 (备考) 和 9.32 (参比制剂) mg·h/l。代谢产物 4 ′-羟基-尼美舒利的相应值分别为 11.95、 5.59 mg·h/L。平均峰值尼美舒利血浆浓度 (Cmax) [代谢产物在括号中的值] 被 4.67 (163) mg/L 为测试准备和 1.60 (0.65) 为参比制剂毫克/升。此外，尼美舒利比例计算 Cmax/AUC0-∞。获得的值是 0.25h−1 (测试) 和 0.18h−1 (参考)。统计比较的所有三个参数 (方差分析和置信区间) 对数变换后表现出显著差异和 bioinequivalence 之间的测试和参考筹备工作。结论: 在这项研究取得的成果，根据通用产品尼美舒利 Dorom 不能视为相当于原始产品 Aulin ® 和因此这两种制剂不能认为可互换产品是根据世界健康组织定义的泛型。
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摘要目的：确定意大利市售两尼美舒利制剂的相对生物利用度[原产品®阿林（备考）和通用产品尼美舒利dorom（参比制剂）]后单次口服的健康志愿者，因为在体外研究表明从阿林®尼美舒利的溶解是更快和更完整的比从通用产品。设计：随机，双向交叉研究。患者和参与者：18名健康男性志愿者。方法：血样长达24小时的两制剂给药后，各含100mg尼美舒利，并使用经过验证的高效液相色谱，紫外检测量化尼美舒利及其主要代谢产物4 -羟基′尼美舒利血浆浓度。结果：该地区从零到无穷大的计算曲线下（AUC0 -∞），用尼美舒利的算术平均值分别为19.93（备考）和9.32（参比制剂）mg·H / L的相应值为4 -羟基代谢物′尼美舒利分别为11.95和5.59毫克·H／L，分别。平均峰浓度（Cmax）尼美舒利[括号]代谢值分别为4.67（1.63）毫克/升的准备，1.60（0.65）毫克/升的参考品的制备。此外，为尼美舒利比Cmax / AUC0 -∞计算。得到的值后−1（测试）和0.18h−1（参考）。所有三个参数的统计比较（方差分析和置信区间）对数变换后表现出明显的差异性和bioinequivalence之间试验制剂与参比制剂。结论：根据本研究的结果，该药尼美舒利dorom不能被视为与原产品®阿林，因此两制剂不能被认为是可互换的产品，根据世界卫生组织定义泛型。
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