Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin 2.5 mg; Drug: Empagliflozin/Metformin FDC; Drug: Empagliflozin 10 mg; Drug: Metformin 500 mg

• Registration Number: NCT02028767
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• 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: 2015-07-24
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Separate tablets	Empagliflozin 2.5 mg	Empagliflozin and Metformin tablets
Fixed Dose Combination (FDC)	Empagliflozin/Metformin FDC	12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Separate tablets	Metformin 500 mg	Empagliflozin and Metformin tablets
Separate tablets	Empagliflozin 10 mg	Empagliflozin and Metformin tablets

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)	1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)

Trial Locations

Locations (1)

1276.24.001 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada