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Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

NCT ID: NCT02084056

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

2014-04-30

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 FDC followed by single tablets of linagliptin and metformin, fasted

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin

Metformin

Intervention Type DRUG

Metformin

Linagliptin/Metformin FDC

Intervention Type DRUG

Linagliptin/Metformin FDC

Single tablets first, fasted

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

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin

Metformin

Intervention Type DRUG

Metformin

Linagliptin/Metformin FDC

Intervention Type DRUG

Linagliptin/Metformin FDC

FDC first, fed

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

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin

Metformin

Intervention Type DRUG

Metformin

Linagliptin/Metformin FDC

Intervention Type DRUG

Linagliptin/Metformin FDC

Single tablets first, fed

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

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin

Metformin

Intervention Type DRUG

Metformin

Linagliptin/Metformin FDC

Intervention Type DRUG

Linagliptin/Metformin FDC

Interventions

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Linagliptin

Linagliptin

Intervention Type DRUG

Metformin

Metformin

Intervention Type DRUG

Linagliptin/Metformin FDC

Linagliptin/Metformin FDC

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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1288.11.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-005144-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1288.11

Identifier Type: -

Identifier Source: org_study_id

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