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Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

NCT ID: NCT01634100

Last Updated: 2014-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

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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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A (Reference)

Empagliflozin (BI 10773), Film-coated tablet, single dose

Group Type EXPERIMENTAL

Probenecid

Intervention Type DRUG

Probenecid

Empagliflozin

Intervention Type DRUG

BI Drug

Rifampicin

Intervention Type DRUG

Rifampicin

B (Test 1)

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

Rifampicin

Empagliflozin

Intervention Type DRUG

BI Drug

C (Test 2)

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily

Group Type EXPERIMENTAL

Probenecid

Intervention Type DRUG

Probenecid

Empagliflozin (BI 10773)

Intervention Type DRUG

BI Drug

Interventions

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Probenecid

Probenecid

Intervention Type DRUG

Rifampicin

Rifampicin

Intervention Type DRUG

Empagliflozin

BI Drug

Intervention Type DRUG

Empagliflozin

BI Drug

Intervention Type DRUG

Rifampicin

Rifampicin

Intervention Type DRUG

Probenecid

Probenecid

Intervention Type DRUG

Empagliflozin (BI 10773)

BI Drug

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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1245.83.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

References

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Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1.

Reference Type DERIVED
PMID: 24491572 (View on PubMed)

Other Identifiers

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2012-000971-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.83

Identifier Type: -

Identifier Source: org_study_id

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