Phase 1 Completed N=48 Randomized Treatment

Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Healthy

Source: ClinicalTrials.gov NCT01811953 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin — 2810; 2580; 2760; 2570 nmol*h/L — p=<0.0001

Summary

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin	2810; 2580; 2760; 2570; 988; 927	<0.0001 sig
PRIMARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin	10400; 9220; 11000; 9140; 9080; 9060	<0.0001 sig
PRIMARY Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin	379; 276; 375; 258; 108; 103	<0.0001 sig
PRIMARY Maximum Measured Concentration of the Analyte in Plasma, Metformin	1580; 1160; 1680; 1180; 1180; 1150	0.0001 sig
SECONDARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin	2770; 2530; 2720; 2510; 962; 903	<0.0001 sig
SECONDARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin	10100; 8960; 10700; 8930; 8870; 8850	<0.0001 sig

Eligibility Criteria

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01811953). 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.