Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations
Status:
COMPLETED
Trial end date:
2025-06-18
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Aya Mohammed Abdel Magid Abdel Hamid
Collaborators:
Advanced Research Center (ARC) Atco Pharma for Pharmaceutical Industries