临床试验/NCT00908271

NCT00908271已完成1 期

Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

AstraZeneca1 个研究点分布在 1 个国家目标入组 7 人开始时间: 2009年7月最近更新: 2016年10月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 7
试验地点: 1
主要终点: Absolute oral bioavailability

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

排除标准

•Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
•Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
•Exposure to significant radiation within 12 months prior to admission to the clinical facility

研究组 & 干预措施

Dapagliflozin

Other

PO and IV

干预措施: Dapagliflozin (Drug)

结局指标

主要结局

Absolute oral bioavailability

时间窗: Within the 3 days after study drug administration

次要结局

Electrocardiograms (ECGs)(Within the 3 days after study drug administration)
Adverse events (AE)(Within the 3 days after study drug administration)
Vital signs(Within the 3 days after study drug administration)
Clinical safety labs(Within the 3 days after study drug administration)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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