Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 12.5 mg empagliflozin; Drug: 5 mg empagliflozin; Drug: 5 mg empagliflozin/850 mg metformin FDC; Drug: 5 mg empagliflozin/500 mg metformin FDC; Drug: 12.5 mg empagliflozin/500 mg metformin FDC; Drug: 500 mg metformin; Drug: 12.5 mg empagliflozin/850 mg metformin FDC; Drug: 850 mg metformin

• Registration Number: NCT02102932
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2014-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-08
• Results First Submitted: 2015-08-21
• Results First Submitted QC: 2015-08-21
• Last Update Submitted: 2015-08-21
• Results First Posted: 2015-09-24
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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
12.5 mg empagliflozin/850 mg metformin	12.5 mg empagliflozin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order
5 mg empagliflozin/500 mg metformin	5 mg empagliflozin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order
12.5 mg empagliflozin/500 mg metformin	12.5 mg empagliflozin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order
12.5 mg empagliflozin/500 mg metformin	500 mg metformin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order
5 mg empagliflozin/500 mg metformin	5 mg empagliflozin/500 mg metformin FDC	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order
5 mg empagliflozin/850 mg metformin	5 mg empagliflozin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order
5 mg empagliflozin/850 mg metformin	5 mg empagliflozin/850 mg metformin FDC	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order
5 mg empagliflozin/500 mg metformin	500 mg metformin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order
12.5 mg empagliflozin/850 mg metformin	12.5 mg empagliflozin/850 mg metformin FDC	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order
5 mg empagliflozin/850 mg metformin	850 mg metformin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order
12.5 mg empagliflozin/500 mg metformin	12.5 mg empagliflozin/500 mg metformin FDC	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order
12.5 mg empagliflozin/850 mg metformin	850 mg metformin	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order

Primary Outcome Measures

Name	Time	Method
AUC(0-∞) for Empagliflozin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity
AUC(0-∞) for Metformin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity
Cmax for Metformin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Maximum measured concentration of the metformin in plasma
Cmax for Empagliflozin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Maximum measured concentration of the empagliflozin in plasma

Secondary Outcome Measures

Name	Time	Method
AUC(0-tz) of Metformin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point
AUC(0-tz) of Empagliflozin	1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration	Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point

Trial Locations

Locations (1)

1276.23.86002 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China