A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers
An Open-Label, Two-Period, Fixed-Sequence Study to Explore the Effects of Multiple Doses of Hydrochlorothiazide on the Pharmacodynamics, Pharmacokinetics, and Safety of Multiple Doses of Canagliflozin in Healthy Subjects
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
Exclusion Criteria:
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:001
Canagliflozin 300 mg once daily and HCTZ 25 mg once daily Period 1: canagliflozin tablets oral 300 mg once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets oral 25 mg once daily for Days 1 to 28 followed by canagliflozin tablets oral 300 mg once daily taken with HCTZ tablets oral 25 mg once daily on Days 29 to 35.. |
Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35.. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Urine glucose concentration
大体时间:At protocol-specified time points up to Day 36 in Period 2
|
At protocol-specified time points up to Day 36 in Period 2
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Plasma concentration of canagliflozin
大体时间:Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma concentration of hydrochlorothiazide (HCTZ)
大体时间:Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
Plasma glucose concentration
大体时间:At protocol-specified time points up to Day 36 in Period 2
|
At protocol-specified time points up to Day 36 in Period 2
|
Blood pressure and heart rate measurements
大体时间:Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
Plasma and urine electrolyte assessment
大体时间:Up to Day 36 in Period 2
|
Up to Day 36 in Period 2
|
The number and type of adverse events reported
大体时间:Up to Day 46 in Period 2
|
Up to Day 46 in Period 2
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR017851
- 28431754DIA1034
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