NCT06450262

Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) Versus Synjardy® 12.5mg/1000mg Film-coated Tablets (12.5mg Empagliflozin/ 1000mg Metformin HCl) in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus Synjardy® 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin/ 1000mg Metformin HCl) in healthy subjects under fed conditions.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
DRUG	Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets	1 tablet of Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets
DRUG	Synjardy® 12.5mg/1000mg film-coated tablets	1 tablet of Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets

Timeline

• Start date: 2024-01-04
• Primary completion: 2024-01-16
• Completion: 2024-03-05
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: Jordan