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国产氟他胺片剂（检品内进口片剂（参比制剂）的生物利用度和药动学比较，通过10名志愿者随机交叉口服单剂量氟他胺片剂（250mg）后，测定血液中活性代谢物2－OH氟他胺的浓度变化。结果表明，两制剂的药动学参数相当接近（P＞0．05）。检品和参比制剂的Cmax为0．88±0．26μg·ml(-1)和0．84±0．23μg！·ml(-1)：Tmax为322±0．83h和273±0．99h；T1／2β为11．37±1．28h和1269±1．66h；AUC0－48为7．16±2．30μg·h·ml(-1)和7．26±1．84μg·h·ml(-1)。用检品和参比制剂的AUC0－48计算的相对生物利用度为97．56±16．08％，经双单侧t检验表明两制剂在中国人中具有生物等效性。
The domestic flutamide tablets (bioavailability and pharmacokinetics of imported tablets (reference preparation) in the seizures were compared, and 10 volunteers were randomized to receive a single dose of flutamide tablets (250 mg) The results showed that the pharmacokinetic parameters of the two preparations were quite close (P> 0.05) .The Cmax of the test product and the reference preparation were 0.88 ± 0.26μg Ml (-1) and 0.84 ± 0.23 μg! Ml (-1): Tmax was 322 ± 0.83 h and 273 ± 0.99 h; T1 / 2 β was 11.37 ± 1.28 h and 1269 ± 1.66h; AUC0-48 was 7.16 ± 2.30μg · h · ml -1 and 7.26 ± 1.84μg · h · ml -1, respectively. The AUC0- 48 calculated relative bioavailability of 97.56 ± 16.08%, by one-sided two-t test showed that the two formulations in the Chinese have bioequivalence.