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Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets

NCT ID: NCT01975220

Last Updated: 2017-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

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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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High dose, fasted

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions

Group Type EXPERIMENTAL

25 mg Empagliflozin/1000 mg Metformin XR, FDC

Intervention Type DRUG

Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

1 tablet Empagliflozin/2 tablets Metformin XR

Intervention Type DRUG

Active Comparator: 1x empagliflozin/2x metformin XR tablets

High dose, fed

1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions

Group Type EXPERIMENTAL

Empagliflozin/Metformin XR, FDC

Intervention Type DRUG

Experimental: high dose empagliflozin/metformin XR, FDC tablet

1 tablet Empagliflozin/2 tablets Metformin XR

Intervention Type DRUG

Active Comparator: 1x empagliflozin/2x metformin XR tablets

Low dose, fasted

2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions

Group Type EXPERIMENTAL

Empagliflozin/Metformin XR FDC

Intervention Type DRUG

Experimental: low dose empagliflozin/metformin XR, FDC tablet

1 tablet Empagliflozin/3 tablets Metformin XR

Intervention Type DRUG

Active Comparator: 1x empagliflozin/3x metformin XR tablets

Interventions

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Empagliflozin/Metformin XR, FDC

Experimental: high dose empagliflozin/metformin XR, FDC tablet

Intervention Type DRUG

Empagliflozin/Metformin XR FDC

Experimental: low dose empagliflozin/metformin XR, FDC tablet

Intervention Type DRUG

25 mg Empagliflozin/1000 mg Metformin XR, FDC

Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

Intervention Type DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1x empagliflozin/2x metformin XR tablets

Intervention Type DRUG

1 tablet Empagliflozin/3 tablets Metformin XR

Active Comparator: 1x empagliflozin/3x metformin XR tablets

Intervention Type DRUG

1 tablet Empagliflozin/2 tablets Metformin XR

Active Comparator: 1x empagliflozin/2x metformin XR tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy males or females
2. Age 18-50 years (incl)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)
4. Subjects must be able to understand and comply with study requirements

Exclusion Criteria

Any deviation from healthy condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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1276.13.1 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1276.13

Identifier Type: -

Identifier Source: org_study_id

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