Bioequivalence of Imeglimin Tablet Formulations

Phase 1

Completed

• Conditions: Bioequivalence
• Interventions: Drug: Imeglimin Reference product; Drug: Imeglimin

• Registration Number: NCT03646331
• Lead Sponsor: Poxel SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2018-09-03
• Primary Completion: 2018-09-27
• Study Completion: 2018-10-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet B in Session 1 and Tablet A in Session 2	Imeglimin Reference product	Tablet A = reference product Tablet B = test product
Tablet A in Session 1 and Tablet B in Session 2	Imeglimin Reference product	Tablet A = reference product Tablet B = test product
Tablet A in Session 1 and Tablet B in Session 2	Imeglimin	Tablet A = reference product Tablet B = test product
Tablet B in Session 1 and Tablet A in Session 2	Imeglimin	Tablet A = reference product Tablet B = test product

Primary Outcome Measures

Name	Time	Method
Pk parameters of imeglimin	from dosing up to 48h	Cmax: peak plasma concentration after dosing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hammersmith Medicines Research (HMR); 🇬🇧 London, United Kingdom