两种片剂剂型口服给药后氯硝西泮的生物利用度比较研究。
Comparative bioavailability study of clonazepam after oral administration of two tablet formulations.
作者信息
Chauhan B L, Sane S P, Revankar S N, Rammamurthy L, Doshi B, Bhatt A D, Bhate V R, Kulkarni R D
机构信息
Novartis India Limited, Churchgate, Mumbai-400 020.
出版信息
J Assoc Physicians India. 2000 Oct;48(10):985-7.
OBJECTIVE
To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand.
METHODS
A two-way randomised cross-over bioavailability study was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of clonazepam by high performance liquid chromatography (HPLC) method.
RESULTS
The mean Cmax, Tmax t1/2 beta and AUC (0-48) for Epitril were: 16.31 +/- 3.07 ng/mL, 1.63 +/- 0.48 h, 46.97 +/- 12.26 h and 207.70 +/- 57.07 ng/ml.h; for reference brand were 19.75 +/- 5.95 ng/mL, 1.42 +/- 0.29 h, 46.88 +/- 11.29 h and 215.70 +/- 50.89 ng/ml.h respectively. These were comparable and the differences were not statistically significant.
CONCLUSION
Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
目的
评估两种品牌的2毫克片剂制剂（Epitril和参比品牌）中氯硝西泮的生物利用度。
方法
在12名健康男性志愿者中进行了一项双向随机交叉生物利用度研究。采用高效液相色谱（HPLC）法对编码血浆样本中的氯硝西泮水平进行分析。
结果
Epitril的平均Cmax、Tmax、t1/2β和AUC(0 - 48)分别为：16.31±3.07纳克/毫升、1.63±0.48小时、46.97±12.26小时和207.70±57.07纳克/毫升·小时；参比品牌分别为19.75±5.95纳克/毫升、1.42±0.29小时、46.88±11.29小时和215.70±50.89纳克/毫升·小时。这些数据具有可比性，差异无统计学意义。
结论
基于上述药代动力学参数，Epitril与参比品牌生物等效。
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