NASACORT BIODISTRIBUTION & KINETICS IN NORMAL VOLUNTEERS

本研究的目的是定量评价按照包装说明经鼻给药后，曲安奈德（Nasacort AQ中的活性成分）在正常志愿者鼻腔中的生物分布随时间的变化。研究设计为单组、开放标签。 PET扫描将以与先前研究中开发并成功使用的相同方式进行。 在PET数据采集期间，将对6名正常志愿者给予配制的放射性药物。 合格受试者将被要求向大学医院核医学部的PET扫描仪报告，在研究期间将静脉导管放置在手臂上进行血样采集。 静脉导管将用于常规药代动力学采样8小时。 PET扫描完成后，志愿者将被送往临床研究中心进行剩余的血液采样和血浆样本处理。

The objective of this study is to quantitatively evaluate the biodistribution of triamcinolone acetonide, the active ingredient in Nasacort AQ, in the nasal cavities of normal volunteers as a function of time following nasal administration according to package directions. The study design is single arm, and open label. PET scanning will be performed in the same fashion as was developed and successfully used in previous studies. The formulated radiopharmaceutical will be administered to six normal volunteers during PET data acquisition. Qualifying subjects will be asked to report to the PET scanner in the Division of Nuclear Medicine at University Hospitals where a venous catheter will be placed in an arm, for blood sampling during the study. The venous catheter will be used for conventional pharmacokinetic sampling for 8 hours. Following the completion of the PET scan, the volunteers will be taken to the Clinical Research Center for the remainder of the blood sampling and processing of the plasma samples.