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Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Linagliptin/metformin

Metformin

Linagliptin

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sites / Locations

1288.20.1 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Linagliptin/metformin

Linagliptin and metformin

Arm Description

fixed dose combination tablet (FDC)

single tablets

Outcomes

Primary Outcome Measures

Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin

AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.

Maximum Concentration (Cmax) of Metformin

Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.

Secondary Outcome Measures

Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin

AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.

Time to Maximum Concentration (Tmax) of Metformin

Time from dosing to the maximum concentration of metformin in plasma.

Terminal Half-life t1/2 of Metformin

The terminal half-life of metformin in plasma is denoted by t1/2.

Full Information

NCT ID

NCT01581931

First Posted

April 19, 2012

Last Updated

June 14, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01581931

Brief Title

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Official Title

Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Linagliptin/metformin

Arm Type

Experimental

Arm Description

fixed dose combination tablet (FDC)

Arm Title

Linagliptin and metformin

Arm Type

Experimental

Arm Description

single tablets

Intervention Type

Drug

Intervention Name(s)

Linagliptin/metformin

Intervention Description

FDC

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

single tablet Metformin

Intervention Type

Drug

Intervention Name(s)

Linagliptin

Intervention Description

single tablet Linagliptin

Primary Outcome Measure Information:

Title

Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin

Description

Time Frame

0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours

Title

Maximum Concentration (Cmax) of Metformin

Description

Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.

Time Frame

0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours

Secondary Outcome Measure Information:

Title

Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin

Description

AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.

Time Frame

0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours

Title

Time to Maximum Concentration (Tmax) of Metformin

Description

Time from dosing to the maximum concentration of metformin in plasma.

Time Frame

0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours

Title

Terminal Half-life t1/2 of Metformin

Description

The terminal half-life of metformin in plasma is denoted by t1/2.

Time Frame

0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 1. Healthy male and female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1288.20.1 Boehringer Ingelheim Investigational Site

City

Biberach

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

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