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

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ClinicalTrials.gov Identifier: NCT01242176
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 XX (Trial Formulation 2) Drug: BI 10773 (Final Formulation) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study Start Date : November 2010
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 10773 Final Formulation
one single film-coated tablet in the morning
Drug: BI 10773 (Final Formulation)
one single film-coated tablet in the morning

Experimental: BI 10773 XX Trial Formulation 2
one single dose tablet in the morning
Drug: BI 10773 XX (Trial Formulation 2)
one single dose tablet in the morning




Primary Outcome Measures :
  1. 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 ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

    Note the standard deviation is actually the coefficient of variation (CV (%)).


  2. 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 ]

    Maximum measured concentration of empagliflozin (empa) in plasma.

    Note the standard deviation is actually the CV (%).



Secondary Outcome Measures :
  1. 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 ]

    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.

    Note the standard deviation is actually the CV (%).




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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


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): NCT01242176


Locations
Germany
1245.51.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01242176     History of Changes
Other Study ID Numbers: 1245.51
2010-022469-81 ( EudraCT Number: EudraCT )
First Posted: November 16, 2010    Key Record Dates
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs