MedTrace Logo

Sotagliflozin Bioequivalence Study

NCT03211195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sotagliflozin (SAR439954)

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2017-08-22
Completion
2017-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211195 on ClinicalTrials.gov