NCT03646331 is a Phase 1 clinical trial of Imeglimin Reference product in Bioequivalence, sponsored by Poxel SA.

Who is sponsoring NCT03646331?

NCT03646331 is sponsored by Poxel SA.

What drugs are being tested in NCT03646331?

Interventions in NCT03646331: Imeglimin Reference product, Imeglimin.

What condition does NCT03646331 study?

NCT03646331 studies Bioequivalence.

Is NCT03646331 still recruiting?

NCT03646331 is currently completed. Last updated 11 January 2019.

Last reviewed 2019-01-11 · How we verify

NCT03646331

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence of Imeglimin Tablet Formulations

Completed Phase 1 Last updated 11 January 2019

What this trial tests

Phase 1 trial testing Imeglimin Reference product in Bioequivalence in 16 participants. Completed in 2 October 2018.

Timeline

3 September 2018

Primary endpoint
27 September 2018

2 October 2018

Quick facts

Lead sponsor	Poxel SA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	3 September 2018
Primary completion	27 September 2018
Estimated completion	2 October 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

Imeglimin Reference product — full drug profile →
Imeglimin (IMEGLIMIN) — full drug profile →

Conditions studied

Bioequivalence — all drugs for Bioequivalence →

Sponsor

Poxel SA — full company profile →

Who can join

Adults 18 to 55, any sex, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bioequivalence

Currently open trials in the same condition.

NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting

Other Poxel SA trials

Trials by the same sponsor.

NCT05441904 — Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects. · Phase 1 · completed
NCT04321343 — Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
NCT03950882 — A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD · Phase 1 · completed
NCT03763877 — A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD · Phase 2 · completed
NCT03886103 — Pharmacokinetics and Metabolism of (14C)-Labelled PXL770 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03646331 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Poxel SA
Last refreshed: 11 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03646331.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing