An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
研究概览
简要总结
The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.
详细描述
This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 55 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg.
排除标准
- •History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
研究组 & 干预措施
001
Canagliflozin/Probenecid
干预措施: Canagliflozin/Probenecid (Drug)
结局指标
主要结局
Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
时间窗: Up to Day 18
Plasma concentrations of probenecid
时间窗: Up to Day 17
次要结局
- Adverse Events(Up to 10 days following Day 18)
- Clinical Laboratory Tests(Up to 10 days following Day 18)
- Vital Signs(Up to 10 days following Day 18)
