A Bioequivalence Study Testing Two Formulations of Sotagliflozin 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
- 66
- 试验地点
- 1
- 主要终点
- AUC 0-72h (area under the curve)
研究概览
简要总结
Primary Objective:
To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects
Secondary Objectives:
- To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions
- To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects
详细描述
Study duration per participant is approximately 103 days including a screening period up to 21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting 7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days after the last dose.
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 Test
One tablet of sotagliflozin administered orally under fasting conditions
干预措施: sotagliflozin (SAR439954) (Drug)
Sotagliflozin Reference
Two tablets of sotagliflozin administered orally under fasting conditions
干预措施: sotagliflozin (SAR439954) (Drug)
结局指标
主要结局
AUC 0-72h (area under the curve)
时间窗: Day 1 to Day 3 of each period
Truncated AUC 0-72h
Cmax
时间窗: Day 1 of each period
Maximum plasma concentration observed
次要结局
- Clinical laboratory tests(Day 1 to Day 7 of each period)
- Time to reach Cmax (tmax)(Day 1 of each period)
- Terminal half-life (t1/2z)(Day 1 to Day 7 of each period)
- Electrocardiograms (ECGs)(Day 1 to Day 7 of each period)
- Area under the curve (AUC)(Day 1 to Day 7 of each period)
- Area under the plasma concentration versus time curve (AUClast)(Day 1 to Day 7 of each period)
- Adverse events(Day 1 to Day 7 of each period)
- Vital signs(Day 1 to Day 7 of each period)