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首页> 外文期刊>Arzneimittel-Forschung: =Drug Research >Pharmacokinetics of acamprosate calcium in healthy Chinese subjects after oral administration of three dosage levels.
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Pharmacokinetics of acamprosate calcium in healthy Chinese subjects after oral administration of three dosage levels.

机译:口服三种剂量水平的健康中国人体内阿坎酸钙的药代动力学。

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摘要

To study the pharmacokinetics of acamprosate calcium (CAS 77337-73-6) in healthy Chinese subjects after oral administration of three dosage levels, 12 healthy subjects were divided into three groups and given a single oral dose of 333 or 666 or 1332 mg acamprosate calcium (enteric coated tablet). A sensitive liquid chromatography-tandem mass spectrometry method (LC-MS-MS) was used for the determination of acamprosate calcium in plasma. Both, a non-compartmental and compartmental method were used for analysis of kinetics parameters. The main pharmacokinetic parameters of the 333, 666 and 1322 mg regimen groups were as follows: tmax 7.5 +/- 2.6 h, 7.4 +/- 2.2 h, 8.1 +/- 3.1 h, Cmax 134.8 +/- 103.9 ng/mL, 297.5 +/- 188.1 ng/mL, 385.4 +/- 155.7 ng/mL, t1/2 13.3 +/- 11.4 h, 17.9 +/- 18.1 h, 15.1 +/- 9.1 h, AUC(0-t) 1772 +/- 1323 ng x h/mL, 3709 +/- 1195 ng x h/mL, 6421 +/- 2486 ng x h/mL, respectively. Statistical analysis of AUC/D showed that AUCs increased linearly with the administered dose. The kinetic process of acamprosate calcium was best fitted to a one-compartment model.
机译:为了研究三种剂量水平的中国健康受试者中阿坎酸钙(CAS 77337-73-6)的药代动力学,将12位健康受试者分为三组,并单次口服333或666或1332 mg阿坎酸钙(肠溶片)。灵敏液相色谱-串联质谱法(LC-MS-MS)用于测定血浆中的阿坎酸钙。非隔室和隔室方法均用于动力学参数分析。 333、666和1322 mg方案组的主要药代动力学参数如下:tmax 7.5 +/- 2.6 h,7.4 +/- 2.2 h,8.1 +/- 3.1 h,Cmax 134.8 +/- 103.9 ng / mL, 297.5 +/- 188.1 ng / mL,385.4 +/- 155.7 ng / mL,t1 / 2 13.3 +/- 11.4 h,17.9 +/- 18.1 h,15.1 +/- 9.1 h,AUC(0-t)1772 +分别为1323 ng xh / mL,3709 +/- 1195 ng xh / mL,6421 +/- 2486 ng xh / mL。 AUC / D的统计分析表明,AUCs随给药剂量呈线性增加。阿坎酸钙的动力学过程最适合于一室模型。

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