Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01242176
First received: November 10, 2010
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: BI 10773 XX (Trial Formulation 2)
Drug: BI 10773 (Final Formulation)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Empa FF / Empa TF2 Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
Empa TF2 / Empa FF Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.

Participant Flow for 3 periods

Period 1:   First Intervention
    Empa FF / Empa TF2     Empa TF2 / Empa FF  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 7 Days
    Empa FF / Empa TF2     Empa TF2 / Empa FF  
STARTED     12     12  
COMPLETED     11     10  
NOT COMPLETED     1     2  
Adverse Event                 0                 2  
Non-compliant with protocol                 1                 0  

Period 3:   Second Intervention
    Empa FF / Empa TF2     Empa TF2 / Empa FF  
STARTED     11     10  
COMPLETED     11     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Study Overall

An open-label, randomised, two-way crossover study. The two treatments administered were

  • A single dose of empagliflozin (empa) 25mg, final formulation
  • A single dose of empa 25mg, trial formulation 2

Between drug administrations there was a washout period of at least 7 days.


Baseline Measures
    Study Overall  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  36.3  ± 9.8  
Gender  
[units: participants]
 
Female     10  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Curve 0 to Infinity (AUC0-∞)   [ Time Frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

2.  Primary:   Maximum Measured Concentration (Cmax)   [ Time Frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]

3.  Secondary:   Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)   [ Time Frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01242176     History of Changes
Other Study ID Numbers: 1245.51, 2010-022469-81
Study First Received: November 10, 2010
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