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NCT03387657 · ClinicalTrials.gov registry record · Phase 1
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03387657 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 16 participants.
The verdict
NCT03387657, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Interventions
- DRUG Hydrochlorothiazide
- DRUG Sotagliflozin (SAR439954)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2018-03-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03387657
The ClinicalTrials.gov registry entry for NCT03387657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 2 interventions - of which Hydrochlorothiazide is the first listed.
NCT03387657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03387657 about?
NCT03387657 is a clinical study titled "A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide". Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ * ...
What is the current status of trial NCT03387657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-01-03. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT03387657?
The interventions under investigation include: Hydrochlorothiazide (DRUG), Sotagliflozin (SAR439954) (DRUG).
Who is sponsoring clinical trial NCT03387657?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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