Sotagliflozin Bioequivalence Study

Type 2 Diabetes Mellitus Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT03211195
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2017
• Completion date: August 22, 2017