NCT03417076撤回1 期
A Phase 1, Single Center, Open-label, Single Period, Non-randomized Study to Determine the Absolute Bioavailability of Bexagliflozin Tablets Following a Single Oral Dose Co-administered With an Intravenous Microtracer Dose of 14C-Bexagliflozin in Healthy Male Subjects
Theracos1 个研究点 分布在 1 个国家开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- absolute bioavailability (Fp.o.) of bexagliflozin tablets
研究概览
简要总结
The purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- •no nicotine and tobacco consumption in the past 3 months
- •willing and able to be confined to the clinical research facility as required by the protocol
排除标准
- •clinically significant history of allergy to drugs or latex
- •history of alcohol or drug dependence in the past 12 months.
- •donation of a significant amount of blood in the past 2 months
- •willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic
- •exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
研究组 & 干预措施
Bexagliflozin
Experimental
Each subject will receive a single oral dose of bexagliflozin tablets, 20 mg, followed by a single IV dosing of < 30 ug 14C-bexagliflozin in 0.9% saline solution).
干预措施: Bexagliflozin (Drug)
结局指标
主要结局
absolute bioavailability (Fp.o.) of bexagliflozin tablets
时间窗: Up to 48 hours
oral to IV ratio of dose-normalized AUC0-inf (area under the plasma concentration time curve extrapolated to infinity)
次要结局
- adverse events(Up to 3 days)
研究者
研究点 (1)
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