NCT01811953

Brief Summary

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2013

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

Study Start

First participant enrolled

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.2 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

2 months

First QC Date

March 13, 2013

Results QC Date

June 26, 2015

Last Update Submit

June 26, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin

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

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

  • Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin

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

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

  • Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin

    Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin

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

  • Maximum Measured Concentration of the Analyte in Plasma, Metformin

    Cmax: maximum measured concentration of the analyte in plasma for Metformin

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

Secondary Outcomes (2)

  • Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin

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

  • Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin

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

Study Arms (6)

1 Empagliflozin/Metformin (T)

EXPERIMENTAL

fixed-dose-combination tablet, oral with 240 ml water under fasted conditions

Drug: Empagliflozin/Metformin

2 Empagliflozin/Metformin (T)

EXPERIMENTAL

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Drug: Empagliflozin/Metformin

3 Empagliflozin + Metformin (R)

EXPERIMENTAL

tablets, oral with 240 ml water under fasted conditions

Drug: EmpagliflozinDrug: Metformin

4 Empagliflozin + Metformin (R)

EXPERIMENTAL

tablets, oral with 240 ml water under fed conditions

Drug: EmpagliflozinDrug: Metformin

5 Empagliflozin/Metformin (T)

EXPERIMENTAL

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Drug: Empagliflozin/Metformin

6 Empagliflozin + Metformin (R)

EXPERIMENTAL

tablets, oral with 240 ml water under fed conditions

Drug: EmpagliflozinDrug: Metformin

Interventions

EmpagliflozinDRUG

medium dose oral administration

4 Empagliflozin + Metformin (R)
MetforminDRUG

oral administration

4 Empagliflozin + Metformin (R)
Empagliflozin/MetforminDRUG

low dose of Empagliflozin

5 Empagliflozin/Metformin (T)

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)

1276.8.1 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

March 13, 2013

First Posted

March 15, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 27, 2015

Results First Posted

July 27, 2015

Record last verified: 2015-06

Locations

DE(1)