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

NCT ID: NCT01581931

Last Updated: 2013-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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Linagliptin/metformin

fixed dose combination tablet (FDC)

Group Type EXPERIMENTAL

Linagliptin/metformin

Intervention Type DRUG

FDC

Linagliptin and metformin

single tablets

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

single tablet Metformin

Linagliptin

Intervention Type DRUG

single tablet Linagliptin

Interventions

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Linagliptin/metformin

FDC

Intervention Type DRUG

Metformin

single tablet Metformin

Intervention Type DRUG

Linagliptin

single tablet Linagliptin

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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1288.20.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-005423-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1288.20

Identifier Type: -

Identifier Source: org_study_id