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Study on bioavailability of sumatriptan succinate tablets in healthy Chinese volunteers

机译:舒马曲坦琥珀酸酯片在健康中国志愿者体内的生物利用度研究

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摘要

The bioavailability of two kind of sumatriptan succinate tablets was studied in 22 healthy Chinese volunteers by crossover design. The established bioanalytical method was validated and fitted with the need for pharmacokinetic study in clinical trial. The Comparison of pharmacokinetic parameters of two kinds of sumtriptan succinate tablets after oral single dose suggested that C_(max) t_(max) and t_(1/2) had no significant difference (P_(mean)> 0.05) between test tablets and reference tablets after single dose. The relative bioavailability of the test tablets was 103.6%. Statistic analysis (two-way one-side t-test in C_(max) AUC_(0-infinity) and AUC_(0-t) result exhibited that the test tablets were bioequivalence with the reference tablets.
机译:通过交叉设计,对22名健康的中国志愿者研究了两种舒马曲坦琥珀酸盐片剂的生物利用度。验证了建立的生物分析方法,并符合临床试验中药代动力学研究的需要。两种舒马普坦琥珀酸盐口服单剂给药后药代动力学参数的比较表明,试验片剂与参比制剂之间的C_(max)t_(max)和t_(1/2)无显着性差异(P_(mean)> 0.05)。单剂后服用。测试片剂的相对生物利用度为103.6%。统计分析(在C_(max)AUC_(0-infinity)和AUC_(0-t)中进行双向单侧t检验,表明测试片剂与参考片剂具有生物等效性。

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