NCT07266766

Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Empagliflozin / Metformin HCl XR Tablets	One Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets
DRUG	Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)	One Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg

Timeline

• Start date: 2025-08-05
• Primary completion: 2025-09-24
• Completion: 2025-10-06
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: India