BIOEQUIVALENCE OF VERAPAMIL TABLETS IN SPECIAL POPULATIONS--YOUNG VS. ELDERLY

维拉帕米片在特殊人群中的生物等效性——年轻人与年轻人

• 批准号: 6245414
• 负责人: BRENT G PETTY
• 金额: $ 2.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-05 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6245414
• 关键词: age difference; clinical research; dosage forms; human old age (65+); human subject; pharmacokinetics; verapamil; young adult human (21-34)

The purpose of this study is to determine whether pharmacokinetic bioequivalence of two generic verapamil products compared to a standard verapamil product can be demonstrated in two groups of test subjects; healthy individuals between 18 and 45 years of age, and healthy subjects 65 years of age or older. Pharmacodynamic assessment will also be included. During the course of the period covered by this report, we completed the clinical portion of the study. As in previous periods, there were no serious adverse events among our subjects. Mild to moderate constipation occasionally developed in some of the elderly subjects.

本研究的目的是确定药代动力学是否 两种维拉帕米仿制药与标准品的生物等效性 维拉帕米产品可在两组试验受试者中得到证实; 年龄在18至45岁之间的健康个体和健康受试者 65岁或以上。 还将进行药效学评估 包括. 在本报告所述期间，我们完成了 研究的临床部分。 与以往各期一样， 严重的不良事件。 轻度至中度 在一些老年受试者中偶尔发生便秘。