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Pharmacokinetics and Tolerability of Sublingual Fentanyl in Healthy Japanese and Caucasian Volunteers: Phase I, Open-Label Single-Dose Study

机译：健康日本和白种人志愿者舌下芬太尼的药代动力学和耐受性：I期，开放标签单剂量研究

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This study investigated whether the pharmacokinetics of sublingual fentanyl (SLF), a fentanyl citrate formulation for breakthrough pain (BTP) in opioid-tolerant cancer patients, are influenced by ethnicity. Twenty-one healthy Japanese and Caucasian volunteers (20-45 years) were to receive single doses of SLF (50, 100, 150 and 200 mug) at >=3-day intervals. Area under the plasma concentration-time curve and maximum plasma concentration (C_max) increased with ascending dose, and were statistically similar between ethnic groups (p=0.6274 and p=0.8943, respectively). Time to first observed plasma fentanyl concentration was 10-15 min and time to C_max was 30-45 min, for all doses. SLF was well tolerated, irrespective of ethnicity. The findings suggest that SLF should be an effective analgesic for cancer BTP in Japanese and Caucasian patients.

机译：本研究研究了舌下芬太尼（SLF）的药代动力学是否受到阿片类耐受性癌症患者的突破性疼痛（BTP）的芬太尼植物制剂，受民族的影响。二十一体健康的日本和白种人志愿者（20-45岁）是接受单剂量的SLF（50,100,150和200杯）> = 3天间隔。等离子体浓度 - 时间曲线下的面积和最大血浆浓度（C_max）随着升序的增加而增加，并且在族群之间存在统计学相似（P = 0.6274和P = 0.8943）。对于所有剂量，首先观察到血浆芬太尼浓度为10-15分钟，时间为30-45分钟。无论种族如何，SLF都耐受良好。研究结果表明，SLF应该是日本和白种人患者中癌症BTP的有效镇痛药。

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《International Pain Clinic Congress》|2008年||共6页
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U. Lorch; F. Farrell; J. Kilborn; M. TamaokaR. Derrick; J. Howell;
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中图分类疼痛;
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Pharmacokinetics and Tolerability of Sublingual Fentanyl in Healthy Japanese and Caucasian Volunteers: Phase I, Open-Label Single-Dose Study

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