Trials / Completed
CompletedNCT03646331
Bioequivalence of Imeglimin Tablet Formulations
A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Poxel SA · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A \[reference product\] and Tablet B \[test product\]), in at least 16 healthy Caucasian volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imeglimin Reference product | Reference product |
| DRUG | Imeglimin | Test product (new formulation tablet) |
Timeline
- Start date
- 2018-09-03
- Primary completion
- 2018-09-27
- Completion
- 2018-10-02
- First posted
- 2018-08-24
- Last updated
- 2019-01-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03646331. Inclusion in this directory is not an endorsement.