PHASE I AND PHARMACOKINETIC STUDIES OF VITAMIN E

维生素 E 的 I 期和药代动力学研究

• 批准号: 3622070
• 负责人: NIKOLAY V DIMITROV
• 金额: $ 20万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-06-26 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3622070
• 关键词: Schistosoma; anthelmintics; clinical trials; drug metabolism; drug screening /evaluation; human subject; human therapy evaluation; pyrazines; schistosomiasis

This contract is divided into two different tasks. The primary goal of these studies is to develop a safety and toxicity profile on Oltipraz so that an appropriate and safe dose for a subsequent risk reduction trial can be established. It is also necessary to obtain required information so that an application for a Phase II IND can be submitted to the FDA prior to a cancer risk reduction trial. A secondary objective is to obtain pharmacokinetic data on Oltipraz, and on its metabolites if possible, so that a maximum body of knowledge concerning the distribution, metabolism, excretion, and toxicity of the compound will be available. Such data may enhance the efficacy and safety of that compound in the prevention trials(s) to be developed subsequently.

该合同分为两个不同的任务。 主要目标是 这些研究是为了开发奥替普拉的安全性和毒性特征，以便 为随后的风险降低试验提供适当且安全的剂量 可以成立。 还需要获取所需的信息 以便可以向 FDA 提交 II 期 IND 申请 在癌症风险降低试验之前。 次要目标是 获得奥替普拉及其代谢物的药代动力学数据，如果 可能，以便最大限度地了解有关 化合物的分布、代谢、排泄和毒性 可用。 此类数据可能会提高该药物的功效和安全性 随后将开发的预防试验中的化合物。