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: September 27, 2012
Last verified: September 2012
  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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability as described by physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), laboratory tests, adverse events, and tolerability assessment by physician [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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
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

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
Last Updated: September 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 20, 2014