NCT03629054

This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills

Bioequivalence of a Low Strength Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal. The assessment of safety and tolerability will be the secondary objective of this trial.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination)	single dose
DRUG	Empagliflozin	single dose
DRUG	Linagliptin	single dose
DRUG	Metformin HCl	single dose

Timeline

• Start date: 2018-08-27
• Primary completion: 2018-11-05
• Completion: 2018-11-05
• First posted: 2018-08-14
• Last updated: 2020-02-21
• Results posted: 2020-02-21

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study