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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03646331

Enrollment

Registered

2018-08-24

Start date

2018-09-03

Completion date

2018-10-02

Last updated

2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence

Brief 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.

Interventions

DRUGImeglimin Reference product

Reference product

DRUGImeglimin

Test product (new formulation tablet)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI : 18.5-29.9 * Body weight ≥ 60 kg * willing to use reliable contraception * able to give fully informed written consent.

Exclusion criteria

* Positive tests for hepatitis B & C, HIV * severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies * drug or alcohol abuse * smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily * over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol \[acetaminophen\] and oral contraception); * participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months * vital signs outside the acceptable range * clinically relevant abnormal findings at the screening assessment; estimated glomerular filtration rate (eGFR) at screening \< 80 mL/min/1.73 m2 * acute or chronic illness * clinically relevant abnormal medical history or concurrent medical condition; * surgery or medical condition that might affect the absorption of medicines; * possibility that volunteer will not cooperate * pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception; * objection by the volunteer's General Practitioner (GP).

Design outcomes

Primary

Measure	Time frame	Description
Pk parameters of imeglimin	from dosing up to 48h	Cmax: peak plasma concentration after dosing

Secondary

Measure	Time frame	Description
PK parameters of Imeglimin	from dosing up to 48h	AUC last: area Under the concentration time curve
Incidence of treatment emergent adverse events (Safety and tolerability)	From Day 1 to Day 15	Incidence of treatment emergent adverse events

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026