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Clinical trial

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference Product of Synjardy XR Tablets 25mg/1000mg in Healthy, Adult, Human Subjects Under Fed Condition.

NCT07266766 is registered in ClinicalTrials.gov with Humanis Saglık Anonim Sirketi as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Test Product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference Product of Synjardy XR Tablets 25mg/1000mg in Healthy, Adult, Human Subjects Under Fed Condition.
Lead sponsor
Humanis Saglık Anonim Sirketi
Phase
Phase 1
Overall status
Completed
Start date
August 5, 2025
Completion date
October 6, 2025
Enrollment
40 (actual)
Sites
1

Conditions

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

type 2 diabetes mellitus (t2dm)