drugset / Trial / NCT03174548
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects. Secondary Objectives: * To evaluate the effect of food on the single-dose pharmacokinetics of the main metabolite (sotagliflozin 3-O-glucuronide) relative to a fasted state in healthy adult male and female subjects. * To investigate the relative bioavailability of sotagliflozin tablet to oral solution under fasting conditions * To evaluate safety and tolerability of single-dose sotagliflozin under fed and fasted conditions in healthy adult male and female subjects.
Timeline
- Start
- 2017-06-12
- Primary completion
- 2017-09-15
- Completion
- 2017-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotagliflozin | Small molecule | — | Oral |