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

November 10, 2010
May 16, 2014
November 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 (%).

  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01242176 on ClinicalTrials.gov Archive Site
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 (%).

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 ]
Not Provided
Not Provided
 
Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
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)

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: BI 10773 XX (Trial Formulation 2)
    one single dose tablet in the morning
  • Drug: BI 10773 (Final Formulation)
    one single film-coated tablet in the morning
  • Experimental: BI 10773 Final Formulation
    one single film-coated tablet in the morning
    Intervention: Drug: BI 10773 (Final Formulation)
  • Experimental: BI 10773 XX Trial Formulation 2
    one single dose tablet in the morning
    Intervention: Drug: BI 10773 XX (Trial Formulation 2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
December 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

Healthy male and female subjects

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01242176
1245.51, 2010-022469-81
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP