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Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

NCT ID: NCT01242176

Last Updated: 2014-06-18

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

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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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BI 10773 Final Formulation

one single film-coated tablet in the morning

Group Type EXPERIMENTAL

BI 10773 (Final Formulation)

Intervention Type DRUG

one single film-coated tablet in the morning

BI 10773 XX Trial Formulation 2

one single dose tablet in the morning

Group Type EXPERIMENTAL

BI 10773 XX (Trial Formulation 2)

Intervention Type DRUG

one single dose tablet in the morning

Interventions

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BI 10773 XX (Trial Formulation 2)

one single dose tablet in the morning

Intervention Type DRUG

BI 10773 (Final Formulation)

one single film-coated tablet in the morning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy male and female subjects
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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1245.51.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-022469-81

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.51

Identifier Type: -

Identifier Source: org_study_id

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