NCT01672788

Brief Summary

The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

August 22, 2012

Results QC Date

June 26, 2015

Last Update Submit

August 4, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

  • Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

  • Empa: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma, per period. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

  • Metformin: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of the analyte in plasma, per period. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary Outcomes (2)

  • Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

  • Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

    1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Study Arms (4)

Test 1

EXPERIMENTAL

fixed dose combination tablet

Drug: Empagliflozin + Metformin

Reference 1

ACTIVE COMPARATOR

empagliflozin tablets and metformin tablet

Drug: EmpagliflozinDrug: Metformin

Test 2

EXPERIMENTAL

fixed dose combination tablet

Drug: Empagliflozin + Metformin

Reference 2

ACTIVE COMPARATOR

empagliflozin tablet and metformin tablet

Drug: MetforminDrug: Empagliflozin

Interventions

EmpagliflozinDRUG

empagliflozin tablets and metformin tablet

Reference 1
Empagliflozin + MetforminDRUG

fixed dose combination tablet (low)

Test 2
MetforminDRUG

empagliflozin tablets and metformin tablet

Reference 1

Eligibility Criteria

Age18 Years - 50 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)

1276.7.1 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
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

August 22, 2012

First Posted

August 27, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 31, 2015

Results First Posted

August 31, 2015

Record last verified: 2015-08

Locations

DE(1)