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Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

NCT ID: NCT01672788

Last Updated: 2015-08-31

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

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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Test 1

fixed dose combination tablet

Group Type EXPERIMENTAL

Empagliflozin + Metformin

Intervention Type DRUG

fixed dose combination tablet (low)

Reference 1

empagliflozin tablets and metformin tablet

Group Type ACTIVE_COMPARATOR

Empagliflozin

Intervention Type DRUG

empagliflozin tablets and metformin tablet

Metformin

Intervention Type DRUG

empagliflozin tablets and metformin tablet

Test 2

fixed dose combination tablet

Group Type EXPERIMENTAL

Empagliflozin + Metformin

Intervention Type DRUG

fixed dose combination tablet (low)

Reference 2

empagliflozin tablet and metformin tablet

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

empagliflozin tablet and metformin tablet

Empagliflozin

Intervention Type DRUG

empagliflozin tablet and metformin tablet

Interventions

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Empagliflozin

empagliflozin tablets and metformin tablet

Intervention Type DRUG

Empagliflozin + Metformin

fixed dose combination tablet (low)

Intervention Type DRUG

Metformin

empagliflozin tablets and metformin tablet

Intervention Type DRUG

Metformin

empagliflozin tablet and metformin tablet

Intervention Type DRUG

Empagliflozin + Metformin

fixed dose combination tablet (low)

Intervention Type DRUG

Empagliflozin

empagliflozin tablet and metformin tablet

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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1276.7.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002277-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.7

Identifier Type: -

Identifier Source: org_study_id