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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin/Metformin; Drug: Empagliflozin; Drug: Metformin

• Registration Number: NCT01811953
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-06
• Results First Submitted: 2015-06-26
• Results First Submitted QC: 2015-06-26
• Last Update Submitted: 2015-06-26
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
5 Empagliflozin/Metformin (T)	Empagliflozin/Metformin	fixed-dose-combination tablet, oral with 240 ml water under fed conditions
1 Empagliflozin/Metformin (T)	Empagliflozin/Metformin	fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
2 Empagliflozin/Metformin (T)	Empagliflozin/Metformin	fixed-dose-combination tablet, oral with 240 ml water under fed conditions
3 Empagliflozin + Metformin (R)	Metformin	tablets, oral with 240 ml water under fasted conditions
3 Empagliflozin + Metformin (R)	Empagliflozin	tablets, oral with 240 ml water under fasted conditions
4 Empagliflozin + Metformin (R)	Empagliflozin	tablets, oral with 240 ml water under fed conditions
4 Empagliflozin + Metformin (R)	Metformin	tablets, oral with 240 ml water under fed conditions
6 Empagliflozin + Metformin (R)	Empagliflozin	tablets, oral with 240 ml water under fed conditions
6 Empagliflozin + Metformin (R)	Metformin	tablets, oral with 240 ml water under fed conditions

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin
Maximum Measured Concentration of the Analyte in Plasma, Metformin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Cmax: maximum measured concentration of the analyte in plasma for Metformin

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin	1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin

Trial Locations

Locations (1)

1276.8.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany