Bioequivalence of Imeglimin Tablet Formulations

Poxel

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: Imeglimin; Drug: Imeglimin Reference product

Study type: Interventional

Funder types: Industry

Identifiers

NCT03646331

PXL008-022

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Tablet A in Session 1 and Tablet B in Session 2

Experimental group

Description:

Tablet A = reference product Tablet B = test product

Treatment:

Drug: Imeglimin Reference product

Drug: Imeglimin

Tablet B in Session 1 and Tablet A in Session 2

Experimental group

Description:

Tablet A = reference product Tablet B = test product

Treatment:

Drug: Imeglimin Reference product

Drug: Imeglimin