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Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

NCT ID: NCT01301742

Last Updated: 2014-06-18

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

2011-02-28

Brief Summary

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To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

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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

Subject to receive one single dose BI 10773

Group Type ACTIVE_COMPARATOR

BI 10773

Intervention Type DRUG

1 tablet single dose BI 10773 in the morning

Gemfibrozil

Intervention Type DRUG

Gemfibrozil 600 mg bid for 5 days

BI 10773 plus gemfibrozil

Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

1 tablet single dose BI 10773 in the morning

Interventions

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BI 10773

1 tablet single dose BI 10773 in the morning

Intervention Type DRUG

Gemfibrozil

Gemfibrozil 600 mg bid for 5 days

Intervention Type DRUG

BI 10773

1 tablet single dose BI 10773 in the morning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Healthy male and female subjects

Exclusion Criteria

\- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
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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1245.58.1 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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2010-023152-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.58

Identifier Type: -

Identifier Source: org_study_id

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