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NCT07127094: BEGliTabATCO

Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations

Completed Phase 1 Last updated 24 August 2025
What this trial tests

Phase 1 trial testing Test Product (Glimcoza) in Bioequivalence Study in Healthy Subjects in 29 participants. Completed in 18 June 2025.

Timeline
9 March 2025
Primary endpoint
18 June 2025
18 June 2025

Quick facts

Lead sponsorAya Mohammed Abdel Magid Abdel Hamid
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment29
Start date9 March 2025
Primary completion18 June 2025
Estimated completion18 June 2025
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Aya Mohammed Abdel Magid Abdel Hamid — full company profile →

Who can join

Adults 18 to 55, any sex, with Bioequivalence Study in Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07127094.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing