A SINGLE DOSE, OPEN LABEL STUDY EVALUATING THE PHARMACOKINETICS OF A LOW ORAL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项开放标签的单剂量研究，在4组儿科患者的3到10个中心进行。 ASD患者，年龄5至16岁(含)，按体重分层。共有24名患者 将入选(每组6名患者)。患者将被分配到以下其中之一 以下小组： A组：60~80公斤 B组：40~59公斤 C组：20~39公斤 D组：20公斤以下 入选将按组顺序进行，A组患者首先入选，然后是组 D名患者最后入选。在A组登记后，随后的每个患者组 将在1)对美金刚的药代动力学进行至少评估之后进行登记 前一组中的两名患者和2)在AUC方面的药物暴露 前一组已被确定为小于被认为是 安然无恙。所有患者将接受单剂3毫克的盐酸美金刚MR胶囊。 第一天上午。每个患者参与研究的总持续时间为8 天数(第一天至第八天最后一次PK样本采集)。 在整个研究过程中，将通过监测不良反应、体检、 心电图、生命体征评估和临床实验室检查。 本研究的目的是评价单剂量、低剂量口服阿司匹林的药代动力学。 盐酸美金刚改良型缓释剂在4组孤独症患儿中的应用 按体重分层的。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label single-dose study conducted in 3 to 10 centers in four groups of pediatric patients with ASD, ages 5 to 16 years (inclusive), stratified by weight. A total of 24 patients will be enrolled (6 patients per group). Patients will be assigned to one of the following groups: Group A: 60 to 80 kg Group B: 40 to 59 kg Group C: 20 to 39 kg Group D: less than 20 kg Enrollment will proceed sequentially by group, with Group A patients enrolling first and Group D patients enrolling last. Following enrollment of Group A, each subsequent group of patients will be enrolled after 1) the pharmacokinetics of memantine have been evaluated for at least two patients in the preceding group and 2) drug exposure in terms of AUC for patients in the preceding group has been determined to be less than a predefined limit that is deemed to be safe. All patients will receive a single 3-mg dose of a memantine HCl MR capsule in the morning of Day 1. The total duration of each patient's participation in the study will be 8 days (Day 1 through the last PK sample collection on Day 8). Safety will be assessed throughout the study by monitoring AEs, physical examinations, ECGs, vital sign assessments, and clinical laboratory tests. The purpose of this study is to evaluate the pharmacokinetics of a single, low, oral dose of memantine HCl modified release formulation in four groups of pediatric patients with autism stratified by body weight.