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Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations

NCT07127094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-24

No results posted yet for this study

Summary

An open label, randomized, single-dose, two-sequence, two-period, crossover study to assess the bioequivalence of Imeglimin HCl in Glimcoza 500 mg film coated tablet (Test product) in comparison with Twymeeg® 500 mg tablet (Reference product) in healthy 31 subjects under fasting condition.

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

DRUG

Test Product (Glimcoza)

Tablet formulation

DRUG

Reference (R) Twymeeg®

Tablet formulation

Sponsors & Collaborators

  • Advanced Research Center (ARC)

    collaborator UNKNOWN

  • Atco Pharma for Pharmaceutical Industries

    collaborator UNKNOWN

  • Aya Mohammed Abdel Magid Abdel Hamid

    lead OTHER

Principal Investigators

  • Kamal A. Badr, PhD · Advanced Research Center (ARC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-09
Primary Completion
2025-06-18
Completion
2025-06-18

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07127094 on ClinicalTrials.gov