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
ClinicalTrials.gov Identifier:
NCT01301742
First received: February 22, 2011
Last updated: May 16, 2014
Last verified: May 2014
  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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose ] [ Designated as safety issue: No ]

    Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.

    The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).


  • Total Empa: Maximum Measured Concentration (Cmax) [ Time Frame: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose ] [ Designated as safety issue: No ]

    Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.

    The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).



Secondary Outcome Measures:
  • Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose ] [ Designated as safety issue: No ]

    Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.

    The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).



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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01301742     History of Changes
Other Study ID Numbers: 1245.58, 2010-023152-85
Study First Received: February 22, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
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 July 22, 2014