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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: empagliflozin/metformin; Drug: metformin; Drug: empagliflozin

• Registration Number: NCT02230995
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study Start: 2014-09
• Study First Posted: 2014-09-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-01
• Results First Submitted: 2017-01-19
• Results First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fixed dose combination	empagliflozin/metformin	Single dose empagliflozin/metformin
Single tablets combination	metformin	single doses empagliflozin and metformin
Single tablets combination	empagliflozin	single doses empagliflozin and metformin

Primary Outcome Measures

Name	Time	Method
AUC0-tz of Empagliflozin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
AUC0-tz of Metformin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration
Cmax of Empagliflozin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Maximum measured concentration of empagliflozin in plasma (Cmax)
Cmax of Metformin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Maximum measured concentration of the metformin in plasma

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity of Empagliflozin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
AUC0-infinity of Metformin in Plasma	-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach an der Riss, Germany