NCT03211195

Sotagliflozin Bioequivalence Study

Bioequivalence Study Comparing Sotagliflozin Tablet Commercial Formulation (Test) and Sotagliflozin Tablet Development Formulation (Reference) in Healthy Male and Female Subjects Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2017-06-29
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2017-07-07
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study