An Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754)
研究概览
简要总结
The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.
详细描述
This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must have a Body Mass Index (BMI [weight (kg) / height (m)2]) between 18.5 and 35 kg/m2, inclusive
- •Volunteers must be non-smokers or non-tobacco users
排除标准
- •History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results
研究组 & 干预措施
Metformin + canagliflozin (JNJ-28431754)
Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.
干预措施: Metformin (Drug)
Metformin + canagliflozin (JNJ-28431754)
Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.
干预措施: Canagliflozin (JNJ-28431754) (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754)
时间窗: Up to Day 8
Cmax (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.
The maximum plasma concentration (Cmax) of metformin
时间窗: Up to Day 8
Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754)
时间窗: Up to Day 8
AUC (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.
The area under the plasma concentration-time curve (AUC) for metformin
时间窗: Up to Day 8
AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).
24-hour urine glucose excretion
时间窗: Up to Day 10
24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
24-hour area under the serum glucose concentration-time curve
时间窗: Up to Day 8
24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(up to 18 days)