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NCT03211195 · ClinicalTrials.gov registry record · Phase 1
Sotagliflozin Bioequivalence Study
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT03211195: Completed Phase 1 study, sponsored by Sanofi.
NCT03211195 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03211195, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions. * To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.
Primary Outcome
Sotagliflozin: Maximum plasma concentration (Cmax)
Interventions
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2017-08-22 |
| Phase | Phase 1 |
What the finished NCT03211195 record still lists
NCT03211195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 1 intervention - of which Sotagliflozin (SAR439954) is the first listed.
NCT03211195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03211195 about?
NCT03211195 is a clinical study titled "Sotagliflozin Bioequivalence Study". Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. Secondary Objectives: * To evaluate the single-dose ph...
What is the current status of trial NCT03211195?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2017-06-29. Estimated completion is 2017-08-22.
What interventions are being tested in trial NCT03211195?
The interventions under investigation include: Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03211195?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03211195's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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