NCT01844531

Brief Summary

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal. The assessment of safety and tolerability will be an additional objective of this trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2013

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

April 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

April 29, 2013

Results QC Date

June 26, 2015

Last Update Submit

June 26, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-∞ for Empagliflozin

    AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

  • AUC0-∞ for Metformin

    AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

  • Cmax for Empagliflozin

    Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

  • Cmax for Metformin

    Cmax (maximum measured concentration of the analyte in plasma) for Metformin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

Secondary Outcomes (2)

  • AUC0-tz for Empagliflozin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

  • AUC0-tz for Metformin

    1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake

Study Arms (4)

FDC empagliflozin dose 1 and metformin

EXPERIMENTAL

fix dose combination tablet after intake of a high fat, high caloric meal

Drug: empagliflozin and metformin

empagliflozin dose 1 + metformin tablets

ACTIVE COMPARATOR

single tablets after intake of a high fat, high caloric meal

Drug: empagliflozinDrug: metformin (Glucophage®)

FDC empagliflozin dose 2 and metformin

EXPERIMENTAL

fix dose combination tablet after intake of a high fat, high caloric meal

Drug: empagliflozin and metformin

empagliflozin dose 2 + metformin tablets

ACTIVE COMPARATOR

single tablets after intake of a high fat, high caloric meal

Drug: metformin (Glucophage®)Drug: empagliflozin

Interventions

empagliflozinDRUG

single tablet empagliflozin

empagliflozin dose 1 + metformin tablets
metformin (Glucophage®)DRUG

single tablet metformin

empagliflozin dose 1 + metformin tablets
empagliflozin and metforminDRUG

FDC tablet empagliflozin and metformin

FDC empagliflozin dose 1 and metformin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects
  • Subjects must be able to understand and comply with study requirements
  • Age 18 to 50 years
  • Body mass index (BMI) 18.5 to 29.9 kg/m2

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1276.6.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

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
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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

April 29, 2013

First Posted

May 1, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 27, 2015

Results First Posted

July 27, 2015

Record last verified: 2015-06

Locations

DE(1)