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Trial record 93 of 1433 for:    Area Under Curve AND tablet

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

Tracking Information
First Submitted Date  ICMJE November 10, 2010
First Posted Date  ICMJE November 16, 2010
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE June 18, 2014
Last Update Posted Date June 18, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • 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 (%)).
  • 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 (%).
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
  • 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 ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 10 weeks ]
  • 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 ]
Change History Complete list of historical versions of study NCT01242176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
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 (%).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Healthy male and female subjects

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01242176
Other Study ID Numbers  ICMJE 1245.51
2010-022469-81 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

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