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Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

NCT ID: NCT01811953

Last Updated: 2015-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-05-31

Brief Summary

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Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

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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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1 Empagliflozin/Metformin (T)

fixed-dose-combination tablet, oral with 240 ml water under fasted conditions

Group Type EXPERIMENTAL

Empagliflozin/Metformin

Intervention Type DRUG

medium dose of Empagliflozin oral administration

2 Empagliflozin/Metformin (T)

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Group Type EXPERIMENTAL

Empagliflozin/Metformin

Intervention Type DRUG

medium dose of Empagliflozin oral administration

3 Empagliflozin + Metformin (R)

tablets, oral with 240 ml water under fasted conditions

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

medium dose oral administration

Metformin

Intervention Type DRUG

oral administration

4 Empagliflozin + Metformin (R)

tablets, oral with 240 ml water under fed conditions

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

medium dose oral administration

Metformin

Intervention Type DRUG

oral administration

5 Empagliflozin/Metformin (T)

fixed-dose-combination tablet, oral with 240 ml water under fed conditions

Group Type EXPERIMENTAL

Empagliflozin/Metformin

Intervention Type DRUG

low dose of Empagliflozin

6 Empagliflozin + Metformin (R)

tablets, oral with 240 ml water under fed conditions

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

low dose of Empagliflozin oral administration

Metformin

Intervention Type DRUG

oral administration

Interventions

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Empagliflozin

medium dose oral administration

Intervention Type DRUG

Metformin

oral administration

Intervention Type DRUG

Empagliflozin

low dose of Empagliflozin oral administration

Intervention Type DRUG

Empagliflozin/Metformin

low dose of Empagliflozin

Intervention Type DRUG

Metformin

oral administration

Intervention Type DRUG

Empagliflozin/Metformin

medium dose of Empagliflozin oral administration

Intervention Type DRUG

Empagliflozin

medium dose oral administration

Intervention Type DRUG

Metformin

oral administration

Intervention Type DRUG

Empagliflozin/Metformin

medium dose of Empagliflozin oral administration

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

50 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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1276.8.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-005156-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.8

Identifier Type: -

Identifier Source: org_study_id

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