drugset / Trial / NCT03414723

A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril

NCT03414723

Phase 1 Completed 16 enrolled Sanofi
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2018-01-15
Primary completion
2018-03-10
Completion
2018-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramipril Small molecule Oral
Subject Sotagliflozin Small molecule Oral

Indications