NCT01189201

Brief Summary

The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison. The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison. An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 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

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

August 25, 2010

Results QC Date

March 10, 2015

Last Update Submit

March 10, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

  • Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Empagliflozin: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)

    Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show 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, 72h after drug administration

  • Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)

    Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show 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, 72h after drug administration

Secondary Outcomes (9)

  • Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)

    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, 72h after drug administration

  • Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)

    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, 72h after drug administration

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

    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, 72h after drug administration

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

    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, 72h after drug administration

  • Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)

    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, 72h after drug administration

  • +4 more secondary outcomes

Study Arms (4)

BI 10773/linagliptin FDC SID

EXPERIMENTAL

medium single dose ofBI 10773/linagliptin FDC (Formulation A1)

Drug: BI 10773/linagliptin

BI 10773/linagliptin SID

EXPERIMENTAL

medium single dose of mono components BI 10773/linagliptin

Drug: BI 10773/linagliptin SID

BI 10773/linagliptin FDC

EXPERIMENTAL

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Drug: BI 10773/linagliptin FDC

BI 10773/linagliptin

EXPERIMENTAL

medium single dose of BI 10773/linagliptin FDC (Formulation A3)

Drug: BI 10773/linagliptin

Interventions

BI 10773/linagliptinDRUG

medium single dose of BI 10773/linagliptin FDC (Formulation A1)

BI 10773/linagliptin FDC SID
BI 10773/linagliptin SIDDRUG

medium single dose of mono components BI 10773/linagliptin

BI 10773/linagliptin SID
BI 10773/linagliptin FDCDRUG

medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

BI 10773/linagliptin FDC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male and female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1275.3.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

  • Glund S, Mattheus M, Runge F, Rose P, Friedrich C. Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet . Int J Clin Pharmacol Ther. 2017 Apr;55(4):355-367. doi: 10.5414/CP202929.

    PMID: 28290274DERIVED

MeSH Terms

Interventions

empagliflozinLinagliptin

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
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 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Last Updated

March 19, 2015

Results First Posted

March 19, 2015

Record last verified: 2015-03

Locations

DE(1)