Bioequivalence of Imeglimin Tablet Formulations

• Imeglimin Reference product (Drug): Reference product
• Imeglimin (Drug): Test product (new formulation tablet)

Primary outcomes

• Pk parameters of imeglimin [from dosing up to 48h]: Cmax: peak plasma concentration after dosing

Secondary outcomes

• 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

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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).