苯磺酸氨氯地平片相对生物利用度研究

The relative bioavailability of amlodipine besylate tablets in healthy volunteers

目的:研究进口苯磺酸氨氯地平片和国产片在20例健康男性志愿者体内的相对生物利用度。方法:每人每次口服10mg苯磺酸氨氯地平片后,绘制出血药浓度-时间曲线,并计算出主要药动学参数。结果:以进口苯磺酸氨氯地平片为参比,国产苯磺酸氨氯地平片的相对生物利用度为(99.3±18.8)％。结论:2种片剂具有生物等效性。

Objective:To study the relative bioavailability of imported and domestic amlodipine besylate tablets in 20 healthy volunteers. Methods: A single oral dose of 10 mg amlodipine besylate tablets was given to each volunteers, then a drug concentration-time curve was drawn to calculate phar-macokinetic parameters. Results :The relative bioavailability of domestic tablets obtained was (99.3 ± 18.8)%. Conclusion: Statistic analysis shows that the imported and domestic amlodipine besylate tablets are bioequvalent.