Bioequivalence of Imeglimin Tablet Formulations

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646331
• Other study ID #: PXL008-022
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2018
• Est. completion date: October 2, 2018

Study information

• Verified date: January 2019
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bioequivalence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research (HMR)	London

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pk parameters of imeglimin	Cmax: peak plasma concentration after dosing	from dosing up to 48h
Secondary	PK parameters of Imeglimin	AUC last: area Under the concentration time curve	from dosing up to 48h
Secondary	Incidence of treatment emergent adverse events (Safety and tolerability)	Incidence of treatment emergent adverse events	From Day 1 to Day 15