NCT05083949

A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together

Relative Bioavailability of Empagliflozin/Metformin Fixed-dose Combination - Empagliflozin 12.5 mg + Metformin 850mg (Boehringer Ingelheim) Coated Tablet Versus Jardiance® 10mg (Reference 1: Boehringer Ingelheim) Coated Tablet and Glifage® 850mg (Reference 2: Merck S / A. ) Coated Tablet, Administered Together in Healthy Male and Female Subjects Under Fed Conditions: an Open-label, Randomised, Single-dose, Two-way Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FDC 12.5mg empagliflozin/850mg metformin	empagliflozin/metformin
DRUG	Empagliflozin	empagliflozin 10mg (R1)
DRUG	Glifage®	Glifage® 850mg (R2)

Timeline

• Start date: 2021-07-23
• Primary completion: 2021-08-06
• Completion: 2021-09-09
• First posted: 2021-10-19
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study