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Clinical trial

Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions

NCT06823856 is registered in ClinicalTrials.gov with Gedeon Richter Plc. as lead sponsor.

NCT NCT06823856
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Registry record

As filed in ClinicalTrials.gov.

Title
Open-label, Randomized, Two-period Comparative Pharmacokinetics and Bioequivalence Study of Empagliflozin + Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) in Healthy Volunteers Under Fed Conditions
Lead sponsor
Gedeon Richter Plc.
Phase
Phase 1
Overall status
Completed
Start date
May 11, 2025
Completion date
May 21, 2025
Enrollment
64 (actual)
Sites
1

Conditions

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

diabetes mellitus type 2