A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Overview
- Phase
- Phase 1
- Intervention
- sotagliflozin (SAR439954)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- AUC 0-72h (area under the curve)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sotagliflozin Test
One tablet of sotagliflozin administered orally under fasting conditions
Intervention: sotagliflozin (SAR439954)
Sotagliflozin Reference
Two tablets of sotagliflozin administered orally under fasting conditions
Intervention: sotagliflozin (SAR439954)
Outcomes
Primary Outcomes
AUC 0-72h (area under the curve)
Time Frame: Day 1 to Day 3 of each period
Truncated AUC 0-72h
Cmax
Time Frame: Day 1 of each period
Maximum plasma concentration observed
Secondary Outcomes
- 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)