NCT02102932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

March 31, 2014

Results QC Date

August 21, 2015

Last Update Submit

August 21, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC(0-∞) for Empagliflozin

    Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity

    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

  • AUC(0-∞) for Metformin

    Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity

    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

  • Cmax for Empagliflozin

    Maximum measured concentration of the empagliflozin in plasma

    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

  • Cmax for Metformin

    Maximum measured concentration of the metformin in plasma

    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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (4)

12.5 mg empagliflozin/850 mg metformin

EXPERIMENTAL

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 empagliflozinDrug: 850 mg metforminDrug: 12.5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin/850 mg metformin

EXPERIMENTAL

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 FDCDrug: 5 mg empagliflozinDrug: 850 mg metformin

12.5 mg empagliflozin/500 mg metformin

EXPERIMENTAL

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 empagliflozinDrug: 12.5 mg empagliflozin/500 mg metformin FDCDrug: 500 mg metformin

5 mg empagliflozin/500 mg metformin

EXPERIMENTAL

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 empagliflozinDrug: 5 mg empagliflozin/500 mg metformin FDCDrug: 500 mg metformin

Interventions

5 mg empagliflozin/850 mg metformin FDCDRUG

5 mg empagliflozin/850 mg metformin FDC

5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozinDRUG

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

12.5 mg empagliflozin/500 mg metformin
850 mg metforminDRUG

850mg metformin tablet

12.5 mg empagliflozin/850 mg metformin
5 mg empagliflozinDRUG

5 mg empagliflozin

5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozin/850 mg metformin FDCDRUG

12.5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozin/500 mg metformin FDCDRUG

12.5 mg empagliflozin/500 mg metformin FDC

12.5 mg empagliflozin/500 mg metformin
5 mg empagliflozin/500 mg metformin FDCDRUG

5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin
500 mg metforminDRUG

500 mg metformin

12.5 mg empagliflozin/500 mg metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects

You may not qualify if:

  • Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1276.23.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

MeSH Terms

Interventions

empagliflozinMetformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 24, 2015

Results First Posted

September 24, 2015

Record last verified: 2015-08

Locations

CN(1)