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A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

Diabetes Mellitus Clinical Trial

Official title:
An Open Label, 2-treatment, 2-period, Single Sequence Study to Evaluate Pharmacokinetic Drug-drug Interaction Between Ramipril and Sotagliflozin at Steady State in Healthy Subjects

Clinical Trial Summary

Primary Objective: To evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female subjects. Secondary Objectives: - To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its active metabolite (ramiprilat). - To assess the safety and tolerability of multiple-dose sotagliflozin with and without multiple-dose of ramipril.

Clinical Trial Description

The expected duration of subject participation, including Screening of up to 29 days, Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last sotagliflozin dose, is approximately 66 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03414723
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date January 15, 2018
Completion date March 10, 2018
View Details
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