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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 76 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03211195
The ClinicalTrials.gov registry entry for NCT03211195 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sotagliflozin (SAR439954) is the first listed.
NCT03211195 reports 0 study locations.
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.
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