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Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects

NCT ID: NCT02121509

Last Updated: 2016-08-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FDC first, fasted

Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

1 x Linagliptin tablet

Linagliptin/Metformin ER FDC

Intervention Type DRUG

2 x Linagliptin/Metformin ER FDC tablet

Metformin ER

Intervention Type DRUG

3 x Metformin ER tablets

Single tablets first, fasted

single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

1 x Linagliptin tablet

Linagliptin/Metformin ER FDC

Intervention Type DRUG

2 x Linagliptin/Metformin ER FDC tablet

Metformin ER

Intervention Type DRUG

3 x Metformin ER tablets

FDC first, fed

Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

1 x Linagliptin tablet

Linagliptin/Metformin ER FDC

Intervention Type DRUG

2 x Linagliptin/Metformin ER FDC tablet

Metformin ER

Intervention Type DRUG

3 x Metformin ER tablets

Single tablets first, fed

single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

1 x Linagliptin tablet

Linagliptin/Metformin ER FDC

Intervention Type DRUG

2 x Linagliptin/Metformin ER FDC tablet

Metformin ER

Intervention Type DRUG

3 x Metformin ER tablets

Interventions

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Linagliptin

1 x Linagliptin tablet

Intervention Type DRUG

Linagliptin/Metformin ER FDC

2 x Linagliptin/Metformin ER FDC tablet

Intervention Type DRUG

Metformin ER

3 x Metformin ER tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Healthy male or female subjects

Exclusion Criteria

\- Any relevant deviation from healthy condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

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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1288.10.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-005143-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1288.10

Identifier Type: -

Identifier Source: org_study_id

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