Bioequivalence Study Comparing Sotagliflozin Tablet Commercial Formulation (Test) and Sotagliflozin Tablet Development Formulation (Reference) in Healthy Male and Female Subjects Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Assessment of PK parameter: AUClast
研究概览
简要总结
Primary Objective:
To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects.
Secondary Objectives:
- To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions.
- To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.
详细描述
The study duration per subject will be 36-99 days and will consist of a screening period of 2 to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days between each dose administration, and a final follow up visit 10-15 days after final dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sotagliflozin - Commerical
Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions
干预措施: Sotagliflozin (SAR439954) (Drug)
Sotagliflozin -Development
Healthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator
干预措施: Sotagliflozin (SAR439954) (Drug)
结局指标
主要结局
Assessment of PK parameter: AUClast
时间窗: From 0 to 120 hours after SAR439954 intake
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Assessment of PK (pharmacokinetic) parameter: Cmax
时间窗: From 0 to 120 hours after SAR439954 intake
Sotagliflozin: Maximum plasma concentration (Cmax)
Assessment of PK parameter: AUC
时间窗: From 0 to 120 hours after SAR439954 intake
Sotagliflozin: Area under the concentration-time curve from 0 to infinity
次要结局
- Assessment of PK parameter: AUC(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: AUClast(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: t1/2(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: Vz/F(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: Tmax(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: CL/F(From 0 to 120 hours after SAR439954 intake)
- Assessment of PK parameter: Cmax(From 0 to 120 hours after SAR439954 intake)
- Treatment emergent adverse events (TEAE)(From 0 to 144 hours after SAR439954 intake)