全身和局部药物动力学的比较可乐定Mucoadhesive颊平板电脑与参考可乐定在健康志愿者口服药片:非盲随机交叉试验。
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Vasseur B,杜福尔Houdas L,古德温H,哈瑞斯K,被纽约,钦斯
全身和局部药物动力学的比较可乐定Mucoadhesive颊平板电脑与参考可乐定在健康志愿者口服药片:非盲随机交叉试验。
副词。2017年8月,34 (8):2022 - 2032。doi: 10.1007 / s12325 - 017 - 0585 - 9。Epub 2017年7月19日。
- PubMed ID
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28726169 (在PubMed]
- 文摘
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作品简介:可乐定mucoadhesive含片(MBT)是一种新型输送系统导致可乐定的浓度高和持续的口腔。在二期临床试验中,可乐定MBT减少严重的口腔粘膜炎的发病率(OM)与安慰剂相比在头部和颈部癌症患者接受放化疗。本研究比较了药物动力学(PK),可乐定MBT的安全性和耐受性与口服平板(OT)的引用。方法:这是一个随机,三,单剂量交叉研究36 18-50岁健康受试者。14天内资格评估第一剂量。小鬼在禁食状态管理每个治疗周期的第一天。PK样本收集24 h(唾液)/ 96 h(血液)可乐定浓度的测量。安全性和耐受性进行了评估,在指定的时间在整个研究。洗脱期至少7天观察政府之间。结果:可乐定MBT(50和100 microg)应用于上牙龈导致dose-proportional增加唾液(C麦克斯和AUC0-t)和等离子体(Cmax和AUC0-inf)可乐定的水平。 Clonidine MBT was considered to mimic a continuous release of clonidine in plasma, significantly decreasing the C max and AUC and increasing the T max when compared with the reference clonidine HCl tablets. Clonidine MBT exhibited high and prolonged concentrations in saliva where concentrations with the clonidine HCl tablet were negligible. Clonidine MBT exhibited a favourable safety profile with significantly fewer subjects reporting AEs (dry mouth and fatigue) and a reduction in blood pressure when compared to the reference clonidine HCl tablets. CONCLUSION: Clonidine MBT is well tolerated and exhibits proportional saliva and plasma PK over the 50-100-microg dose level. The MBT results in higher saliva concentrations and lower systemic exposure than OT, which was associated with a trend towards fewer adverse events and less dry mouth, fatigue and hypotensive effect. FUNDING: Onxeo SA. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02548806.
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- 药物