Bioequivalence of Imeglimin Tablet Formulations

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Imeglimin Reference product
* Drug: Imeglimin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet A in Session 1 and Tablet B in Session 2<br>Tablet A = reference product Tablet B = test product | Drug: Imeglimin Reference product<br>* Reference product<br>Drug: Imeglimin<br>* Test product (new formulation tablet)<br>|
| Experimental: Tablet B in Session 1 and Tablet A in Session 2<br>Tablet A = reference product Tablet B = test product | Drug: Imeglimin Reference product<br>* Reference product<br>Drug: Imeglimin<br>* Test product (new formulation tablet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pk parameters of imeglimin | Cmax: peak plasma concentration after dosing | from dosing up to 48h | 

Secondary Outcome Measures

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