Trials / Completed
CompletedNCT03618316
Effect of Cimetidine on the PK of Imeglimin
An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin 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
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Imeglimin | 2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8) |
| DRUG | Cimetidine | 400 mg of cimetidine bid from Day 5 to Day 10 |
Timeline
- Start date
- 2018-06-19
- Primary completion
- 2018-07-21
- Completion
- 2018-07-27
- First posted
- 2018-08-07
- Last updated
- 2018-08-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03618316. Inclusion in this directory is not an endorsement.