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Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects

NCT03909451 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.

Secondary Objectives:

* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.

Conditions

Interventions

DRUG

Sotagliflozin (SAR439954)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Placebo

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-04-28
Primary Completion
2019-08-19
Completion
2019-08-19

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT03909451 on ClinicalTrials.gov