Phase 1 Completed N=30 Randomized Treatment

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects

Healthy

Source: ClinicalTrials.gov NCT02230995 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: AUC0-tz of Empagliflozin in Plasma — 5370; 5470 nmol·h/L — p=<0.00001

Summary

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Outcome Measures

Outcome	Result	p-value
PRIMARY AUC0-tz of Empagliflozin in Plasma	5370; 5470	<0.00001 sig
PRIMARY AUC0-tz of Metformin in Plasma	11000; 10800	<0.00001 sig
PRIMARY Cmax of Empagliflozin in Plasma	590; 597	<0.00001 sig
PRIMARY Cmax of Metformin in Plasma	1120; 1060	<0.00001 sig
SECONDARY AUC0-infinity of Empagliflozin in Plasma	5460; 5550	—
SECONDARY AUC0-infinity of Metformin in Plasma	11500; 11000	—

Eligibility Criteria

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy condition.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02230995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.