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Completed

NCT Number: NCT02102932

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

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1276.23.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

Treatment and study plan

5 mg empagliflozin/850 mg metformin FDC

Drug

5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin

Drug

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

850 mg metformin

Drug

850mg metformin tablet

5 mg empagliflozin

Drug

5 mg empagliflozin

12.5 mg empagliflozin/850 mg metformin FDC

Drug

12.5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin/500 mg metformin FDC

Drug

12.5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin FDC

Drug

5 mg empagliflozin/500 mg metformin FDC

500 mg metformin

Drug

500 mg metformin

Primary outcomes

  1. AUC(0-∞) for Empagliflozin

    Time frame: 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

  2. AUC(0-∞) for Metformin

    Time frame: 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

  3. Cmax for Empagliflozin

    Time frame: 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

  4. Cmax for Metformin

    Time frame: 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

Secondary outcomes

  1. AUC(0-tz) of Empagliflozin

    Time frame: 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

  2. AUC(0-tz) of Metformin

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 3, 2014
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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