A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects

Trial Profile

A Phase 1, Randomized, Single-center, Open-label, Three-sequence, Three-period, Three-treatment Crossover Study to Evaluate the Effect of Food on the Single-dose Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability of Sotagliflozin Oral Tablet to Oral Solution in Healthy Male and Female Subjects

Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Sotagliflozin (Primary)
  • Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Sanofi
  • Most Recent Events

    • 10 Aug 2017 Planned End Date changed from 1 Aug 2017 to 7 Sep 2017.
    • 10 Aug 2017 Planned primary completion date changed from 1 Aug 2017 to 7 Sep 2017.
    • 06 Jun 2017 Status changed from not yet recruiting to recruiting.
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