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Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

NCT ID: NCT01211197

Last Updated: 2015-08-21

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

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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

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

3 treatments will be investigated in randomized order

Group Type EXPERIMENTAL

A: BI 10773 / metformin tablet

Intervention Type DRUG

BI 10773 / metformin fixed dose combination tablet in fasted state

B

3 treatments will be investigated in randomized order

Group Type EXPERIMENTAL

B: BI 10773 tablet and metformin tablet

Intervention Type DRUG

BI 10773 and metformin single tablets, administered together in fasted state

C

3 treatments will be investigated in randomized order

Group Type EXPERIMENTAL

C: BI 10773 / metformin tablet

Intervention Type DRUG

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

Interventions

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C: BI 10773 / metformin tablet

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

Intervention Type DRUG

B: BI 10773 tablet and metformin tablet

BI 10773 and metformin single tablets, administered together in fasted state

Intervention Type DRUG

A: BI 10773 / metformin tablet

BI 10773 / metformin fixed dose combination tablet in fasted state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males and females according to the following criteria
2. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Exclusion Criteria

1. Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
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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1276.5.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018589-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.5

Identifier Type: -

Identifier Source: org_study_id

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