Forssell G, Graffner C, Nordlander R, Nyquist O
Eur J Clin Pharmacol. 1980;17(3):209-13. doi: 10.1007/BF00561902.
Plasma concentrations and bioavailability of disopyramide following repeated administration of standard capsules and controlled-release tablets have been compared. Ten patients were randomized into two groups; Group I received disopyramide capsules 150 mg every 6 h for five days. Group II received the same preparations in the reverse order. There was a more rapid rise in disopyramide concentration after the capsules: the maximum of 10.7 +/- 0.6 mumol/l (mean +/- SEM) was reached within 1.8 +/- 0.4 h as compared to 10.6 +/- 0.4 mumol/l within 4.0 +/- 0.3 h after the controlled-release tablets. No significant difference in the fluctuations in individual plasma concentrations during each dose interval at steady state were observed after ordinary capsules compared to controlled-release tablets. The extent of bioavailability was the same. Eight patients reported some side-effects during the capsule period and nine during the controlled-release tablet period.
比较了重复服用标准胶囊和控释片后丙吡胺的血浆浓度和生物利用度。10名患者被随机分为两组;第一组每6小时服用150毫克丙吡胺胶囊,共服用5天。第二组以相反顺序服用相同制剂。服用胶囊后丙吡胺浓度上升更快:在1.8±0.4小时内达到最大值10.7±0.6微摩尔/升(平均值±标准误),而服用控释片后在4.0±0.3小时内达到10.6±0.4微摩尔/升。与控释片相比,普通胶囊在稳态时每个剂量间隔内个体血浆浓度波动无显著差异。生物利用度相同。8名患者在服用胶囊期间报告了一些副作用,9名患者在服用控释片期间报告了副作用。