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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:
ClinicalTrials.gov Identifier:
NCT01301742
First Posted: February 23, 2011
Last Update Posted: June 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

    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 ]

    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number: EudraCT )
First Submitted: February 22, 2011
First Posted: February 23, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Empagliflozin
Gemfibrozil
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors