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NCT03776227 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
A Phase 1 study of Type 2 Diabetes Mellitus and Healthy Subjects, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03776227: Completed Phase 1 study of Type 2 Diabetes Mellitus and Healthy Subjects, sponsored by Sanofi.
NCT03776227 is a Phase 1 study of Type 2 Diabetes Mellitus and Healthy Subjects that has completed, run by Sanofi. The registered enrollment target is 66 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03776227, a Phase 1 study of Type 2 Diabetes Mellitus and Healthy Subjects, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions * To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects
Primary Outcome
Maximum plasma concentration observed
Conditions Studied
Interventions
- DRUG sotagliflozin (SAR439954)
Study Locations (1)
Florida
- Investigational Site Number 8400001 - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2019-04-22 |
| Phase | Phase 1 |
What the finished NCT03776227 record still lists
NCT03776227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which sotagliflozin (SAR439954) is the first listed.
NCT03776227 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03776227 about?
NCT03776227 is a clinical study titled "A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions". Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary Objectives: * To evaluate the single-dose pharmacokinetics of sotag...
What is the current status of trial NCT03776227?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2019-01-25. Estimated completion is 2019-04-22.
What conditions does trial NCT03776227 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Healthy Subjects.
What interventions are being tested in trial NCT03776227?
The interventions under investigation include: sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03776227?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03776227 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03776227's enrollment target sits among peer trials
66 70th of 130 higher than 61 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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.
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