PHARMACOKINETICS OF OPC 41061 IN PTS W/ HYPONATREMIA SECONDARY TO LIVER DISEASE

OPC 41061 在继发于肝病的低钠血症患者中的药代动力学

• 批准号: 6113016
• 负责人: MARION G PETERS
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113016
• 关键词: body fluid balance therapy; clinical research; clinical trials; dietary restriction; diuretics; dosage; drug screening /evaluation; human subject; human therapy evaluation; hyponatremia; liver disorder; liver disorder chemotherapy; nutrition related tag; pharmacokinetics

The overall purpose of this research is: to study the usefulness of OPC-41061, an investigational drug (not yet approved by the FDA) being developed by Otsuka America Pharmaceutical, Inc. for its possible use in the treatment of excess fluid with low sodium levels in liver disease. OPC-41061 a benzaepine derivative being tested for treatment of hypomatremial.... 36 patients in 4 groups will recieve either placebo or one of 4 doses of drug: 5, 10, 15 or 30mg. Patients will be treated with fluid management and dietary restriction equivalent to standard of care. The only addition will be the drug to evaluate safety and efficacy. Patients will be randomized first in the lowest dose of drug. When complete a safety review (not including investigator) will evaluate whether to proceed to the next dosing level. This will occur through the 3 higher doses. Patients will be hospitalized for 7 days for fluid evaluation, then will be outpatients on drug until 14 days and followed for one month.

这项研究的总体目的是：研究OPC-41061的实用性，OPC-41061是一种由Otsuka America Pharmaceutical，Inc。开发的研究药物（尚未获得FDA批准），以便在肝病中使用低钠水平的过量液体来治疗过量的液体。 OPC-41061 A苯甲皮碱衍生物正在测试进行拟驱虫。...36例4组患者将接受安慰剂或4剂药物之一：5、10、15或30mg。患者将接受液体管理和饮食限制，等效于护理标准。 唯一的补充是评估安全性和功效的药物。 患者将首先在最低剂量的药物中随机分组。 完成安全审查（不包括调查人员）时，将评估是否要进入下一个给药水平。这将通过3个较高剂量发生。 患者将住院7天进行液体评估，然后将是药物的门诊病人，直到14天，然后持续一个月。