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