Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

NCT ID: NCT01383356

Last Updated: 2014-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Linagliptin/Metformin medium dosecombo

patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily

Group Type EXPERIMENTAL

Linagliptin/Metformin Combo

Intervention Type DRUG

Fixed dose combination

Linagliptin plus Metformin medium dose

patient to receive two individual tablets: Linagliptin and Metformin (medium dose)

Group Type ACTIVE_COMPARATOR

Metformin Single Tablet

Intervention Type DRUG

Metformin medium doseTablet

Linagliptin Single Tablet

Intervention Type DRUG

Linagliptin Single medium dose Tablet

Interventions

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Metformin Single Tablet

Metformin medium doseTablet

Intervention Type DRUG

Linagliptin/Metformin Combo

Fixed dose combination

Intervention Type DRUG

Linagliptin Single Tablet

Linagliptin Single medium dose Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects.

Exclusion Criteria

1\. Any relevant deviation from healthy conditions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1288.19.1 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1288.19

Identifier Type: -

Identifier Source: org_study_id

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