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

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ClinicalTrials.gov Identifier: NCT02102932
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 5 mg empagliflozin/850 mg metformin FDC Drug: 12.5 mg empagliflozin Drug: 850 mg metformin Drug: 5 mg empagliflozin Drug: 12.5 mg empagliflozin/850 mg metformin FDC Drug: 12.5 mg empagliflozin/500 mg metformin FDC Drug: 5 mg empagliflozin/500 mg metformin FDC Drug: 500 mg metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 12.5 mg empagliflozin/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
Drug: 12.5 mg empagliflozin
10mg empagliflozin tablet and 2.5 mg empagliflozin tablet

Drug: 850 mg metformin
850mg metformin tablet

Drug: 12.5 mg empagliflozin/850 mg metformin FDC
12.5 mg empagliflozin/850 mg metformin FDC

Experimental: 5 mg empagliflozin/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
Drug: 5 mg empagliflozin/850 mg metformin FDC
5 mg empagliflozin/850 mg metformin FDC

Drug: 5 mg empagliflozin
5 mg empagliflozin

Drug: 850 mg metformin
850 mg metformin

Experimental: 12.5 mg empagliflozin/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
Drug: 12.5 mg empagliflozin
10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

Drug: 12.5 mg empagliflozin/500 mg metformin FDC
12.5 mg empagliflozin/500 mg metformin FDC

Drug: 500 mg metformin
500 mg metformin

Experimental: 5 mg empagliflozin/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
Drug: 5 mg empagliflozin
5 mg empagliflozin

Drug: 5 mg empagliflozin/500 mg metformin FDC
5 mg empagliflozin/500 mg metformin FDC

Drug: 500 mg metformin
500 mg metformin




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102932


Locations
China
1276.23.86002 Boehringer Ingelheim Investigational Site
Beijing, China
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02102932     History of Changes
Other Study ID Numbers: 1276.23
First Posted: April 3, 2014    Key Record Dates
Results First Posted: September 24, 2015
Last Update Posted: September 24, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Empagliflozin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs