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首页> 外文期刊>Asian journal of drug metabolism and pharmacokinetics >Bioequivalence evaluation of ibuprofen capsules compared with tablets in healthy Chinese volunteers
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Bioequivalence evaluation of ibuprofen capsules compared with tablets in healthy Chinese volunteers

机译：中国健康志愿者布洛芬胶囊与片剂的生物等效性评价

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Aim The purpose of this study was to determine the pharmacokinetic parameters and assess the bioequivalence of two ibuprofen capsules. Methods The bioequivalence of two products of ibuprofen 400mg was demonstrated in 22 healthy male Chinese volunteers after a single oral administration in a randomized, two-treatment, two-period crossover design with a 1 week washout period. The study was conducted at the Tianjin Metabolic Disease Hospital, Tianjin Medical University. In the morning after an overnight fast (12h) the volunteers were administrated a single dose of either ibuprofen capsule (reference) or tablet (test) 400mg with 200ml water. 3ml of blood samples were collected over a 12-h period after an oral administration. The plasma samples were analyzed using a validated high performance liquid chromatography (HPLC) method with ultraviolet detection at wavelength of 220nm. Results The pharmacokinetic parameters of the two products were calculated from the concentration-time profile. For reference and test products the time to reach maximum concentration (Tmax) was 1.7(+-)0.8h and 3.2(+-)0.6h, the peak concentration (C_(max)) was 23.41(+-)4.00mug/ml and 17.05(+-)3.32ug-mL~, the area under curve to the last measurable concentration (AUC_(0-t)) was 90.80(+-)14.74 ug/ml/h and 81.82(+-)15.06ug h mL_(-1), the area under curve to infinity (AUC_(0-inf)) was 93.36(+-)16.04ug玥 mL~(-1) and 85.17(+-)16.80ug-h mL~(-1), the half-life (T_(1/2)) was 1.87(+-)0.34h and 2.38(+-)0.30h, respectively. The relative bioavailability was 90.05(+-)9.15%, RSD 10.16% fotAUCo., The 90% confidence interval (90% CI) of AUC_(0-t) and AUC_(0-inf) were 86.44%-92.88% and 87.92%-94.65%, 90% CI of C_(max) was 67.78%-77.19%. The non-parametric test of Wilcoxon signed rank test on Tmax showed a very significant difference (P<0.01) between the ibuprofen test (3.2h) and reference (1.7h). Conclusion Based on these statistical inferences it was concluded that there was a bioequivalence on AUC(0-t), AUC_(0-inf) and C_(max) after oral ibuprofen 400mg between the tablet and capsule, but not on Tmax.
机译：目的本研究的目的是确定两个布洛芬胶囊的药代动力学参数并评估其生物等效性。方法在22名健康的中国男性志愿者中，经随机，两次治疗，两个时期的交叉设计，单次口服，冲洗时间为1周，证明了两种布洛芬400mg的生物等效性。该研究在天津医科大学附属天津代谢疾病医院进行。在禁食过夜（12小时）后的第二天早上，给志愿者服用200毫克水400毫克的布洛芬胶囊（参考）或片剂（测试）单剂量。口服后12小时内收集了3ml血液样本。使用经过验证的高效液相色谱（HPLC）方法对血浆样品进行分析，并在220nm波长处进行紫外线检测。结果根据浓度-时间曲线计算了两种产品的药代动力学参数。对于参考和测试产品，达到最大浓度（Tmax）的时间为1.7（±）0.8h和3.2（±）0.6h，峰值浓度（C_（max））为23.41（±）4.00mug / ml和17.05（+-）3.32ug-mL〜，曲线下面积至最后可测量浓度（AUC_（0-t））为90.80（+-）14.74 ug / ml / h和81.82（+-）15.06ug h mL _（-1），至无穷大的曲线下面积（AUC_（0-inf））为93.36（+-）16.04ug玥mL〜（-1）和85.17（+-）16.80ug-h mL〜（-1 ），半衰期（T_（1/2））分别为1.87（+）0.34h和2.38（+）0.30h。相对生物利用度为90.05（±）9.15％，相对标准偏差为10.16％fotAUCo.AUC_（0-t）和AUC_（0-inf）的90％置信区间（90％CI）为86.44％-92.88％和87.92 ％-94.65％，C_（max）的90％CI为67.78％-77.19％。 Wilcoxon秩和检验对Tmax的非参数检验显示，布洛芬检验（3.2h）与参照（1.7h）之间有非常显着的差异（P <0.01）。结论根据这些统计推断，可以得出结论：片剂和胶囊剂之间口服布洛芬400mg后，AUC（0-t），AUC_（0-inf）和C_（max）具有生物等效性，而Tmax则没有。

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