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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01301742
First received: February 22, 2011
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: BI 10773
Drug: Gemfibrozil
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Single Dose BI 10773 Co-administered With Multiple Doses of 600 mg Gemfibrozil Bid Compared to Single Dose Treatment of BI 10773 Alone in Healthy Volunteers ¿ a Phase I, Open-label, Randomised, 2-way Crossover Trial

Resource links provided by NLM:

Drug Information available for: Gemfibrozil
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • AUC 0-8 (area under the concentration-time curve of BI 10773 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of BI 10773 in plasma) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Safety descriptively determined by physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), laboratory tests, adverse events and investigators assessment of global tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-tz (area under the concentration-time curve of BI 10773 in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BI 10773
Subject to receive one single dose BI 10773
 Drug: BI 10773
1 tablet single dose BI 10773 in the morning
Drug: Gemfibrozil
Gemfibrozil 600 mg bid for 5 days
Experimental: BI 10773 plus gemfibrozil
Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days
 Drug: BI 10773
1 tablet single dose BI 10773 in the morning

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301742

Locations
Germany
1245.58.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01301742     History of Changes
Other Study ID Numbers: 1245.58, 2010-023152-85
Study First Received: February 22, 2011
Last Updated: September 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013