NCT03776227

A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (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 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.

Conditions

• Type 2 Diabetes Mellitus
• Healthy Subjects

Interventions

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

Timeline

• Start date: 2019-01-25
• Primary completion: 2019-04-22
• Completion: 2019-04-22
• First posted: 2018-12-14
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study