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Clinical trial

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 Subjects Under Fasting Condition

NCT07127094 is registered in ClinicalTrials.gov with Aya Mohammed Abdel Magid Abdel Hamid as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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 Subjects Under Fasting Condition
Lead sponsor
Aya Mohammed Abdel Magid Abdel Hamid
Phase
Phase 1
Overall status
Completed
Start date
March 9, 2025
Completion date
June 18, 2025
Enrollment
29 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence study in healthy subjects