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
  Purpose

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 Intervention Phase
Healthy
Drug: BI 10773 XX (Trial Formulation 2)
Drug: BI 10773 (Final Formulation)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 (%)).


  • 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 ] [ Designated as safety issue: No ]

    Maximum measured concentration of empagliflozin (empa) in plasma.

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



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 (%).



Enrollment: 24
Study Start Date: November 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

  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: NCT01242176

Locations
Germany
1245.51.1 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

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

ClinicalTrials.gov processed this record on August 28, 2014