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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Gemfibrozil; Drug: BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301742

2010-023152-85 (EudraCT Number)

1245.58

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

BI 10773

Active Comparator group

Description:

Subject to receive one single dose BI 10773

Treatment:

Drug: BI 10773

Drug: Gemfibrozil

Drug: BI 10773

BI 10773 plus gemfibrozil

Experimental group

Description:

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

Treatment:

Drug: BI 10773

Drug: BI 10773