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Bioequivalence of Imeglimin Tablet Formulations

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ClinicalTrials.gov Identifier: NCT03646331
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Imeglimin Reference product Drug: Imeglimin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : October 2, 2018

Arm Intervention/treatment
Experimental: Tablet A in Session 1 and Tablet B in Session 2
Tablet A = reference product Tablet B = test product
Drug: Imeglimin Reference product
Reference product

Drug: Imeglimin
Test product (new formulation tablet)

Experimental: Tablet B in Session 1 and Tablet A in Session 2
Tablet A = reference product Tablet B = test product
Drug: Imeglimin Reference product
Reference product

Drug: Imeglimin
Test product (new formulation tablet)




Primary Outcome Measures :
  1. Pk parameters of imeglimin [ Time Frame: from dosing up to 48h ]
    Cmax: peak plasma concentration after dosing


Secondary Outcome Measures :
  1. PK parameters of Imeglimin [ Time Frame: from dosing up to 48h ]
    AUC last: area Under the concentration time curve

  2. Incidence of treatment emergent adverse events (Safety and tolerability) [ Time Frame: From Day 1 to Day 15 ]
    Incidence of treatment emergent adverse events



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646331


Locations
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United Kingdom
Hammersmith Medicines Research (HMR)
London, United Kingdom
Sponsors and Collaborators
Poxel SA

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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT03646331     History of Changes
Other Study ID Numbers: PXL008-022
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No