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8 名健康受试者单剂量和多剂量交叉口服酮洛芬缓释胶囊的试验制剂和参比制剂。单剂量试验结果表明,达峰时间分别为5 .68 ±1 .73 h 和6 .58 ±1 .92 h ,峰浓度分别为3 .91 ±1 .13 μgml 和3 .15 ±0 .79 μgml ,两种制剂的药动学参数无显著性差异,试验制剂的相对生物利用度为(99 .97 ±9 .63) % 。多剂量试验研究表明,试验制剂和对照制剂的波动系数分别为2 .56 ±0 .47 和2 .55 ±0 .73 ,经统计学处理无显著性差异,表明两种制剂的安全性相当。
Experimental and Reference Preparations of Ketoprofen Sustained Release Capsules at Single and Multidose Intervals in 8 Healthy Subjects. Single dose test results show that the peak time were 5. 68 ± 1. 73 h and 6. 58 ± 1. 92 h, the peak concentrations were 3. 91 ± 1. 13 μgml and 3. 15 ± 0. 79 μg ml. There was no significant difference in pharmacokinetic parameters between the two preparations. The relative bioavailability of the test preparation was (99.97 ± 9 .63)%. Multi-dose trial studies have shown that the coefficient of variation of the test and control preparations is 2 respectively. 56 ± 0. 47 and 2. 55 ± 0. 73, no statistically significant difference, indicating that the safety of the two preparations quite.