NCT02230995

Brief Summary

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2014

Shorter than P25 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

First Submitted

Initial submission to the registry

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 9, 2017

Completed
Last Updated

March 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

August 29, 2014

Results QC Date

January 19, 2017

Last Update Submit

January 19, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-tz of Empagliflozin in Plasma

    Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

  • AUC0-tz of Metformin in Plasma

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

  • Cmax of Empagliflozin in Plasma

    Maximum measured concentration of empagliflozin in plasma (Cmax)

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

  • Cmax of Metformin in Plasma

    Maximum measured concentration of the metformin in plasma

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

Secondary Outcomes (2)

  • AUC0-infinity of Empagliflozin in Plasma

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

  • AUC0-infinity of Metformin in Plasma

    -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

Study Arms (2)

Fixed dose combination

EXPERIMENTAL

Single dose empagliflozin/metformin

Drug: empagliflozin/metformin

Single tablets combination

ACTIVE COMPARATOR

single doses empagliflozin and metformin

Drug: metforminDrug: empagliflozin

Interventions

metforminDRUG

single dose of metformin given as tablets

Single tablets combination
empagliflozin/metforminDRUG

Single dose empagliflozin/metformin given as fixed-dose combination tablet

Fixed dose combination
empagliflozinDRUG

single dose of empagliflozin given as tablet

Single tablets combination

Eligibility Criteria

Age18 Years - 55 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 condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Investigational Site

Biberach an der Riss, Germany

Location

MeSH Terms

Interventions

Metforminempagliflozin

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

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

August 29, 2014

First Posted

September 3, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 9, 2017

Results First Posted

March 9, 2017

Record last verified: 2017-01

Locations

DE(1)