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Bioequivalence of Imeglimin Tablet Formulations

NCT03646331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-01-11

No results posted yet for this study

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

  • Bioequivalence

Interventions

DRUG

Imeglimin Reference product

Reference product

DRUG

Imeglimin

Test product (new formulation tablet)

Sponsors & Collaborators

  • Poxel SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2018-09-27
Completion
2018-10-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646331 on ClinicalTrials.gov