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Trial record 88 of 731 for:    Area Under Curve AND Bioavailability

Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT01451775
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 11, 2011
First Posted Date  ICMJE October 14, 2011
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE June 27, 2014
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]
    Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
  • Maximum Measured Concentration (Cmax) [ Time Frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]
    Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
  • area under the concentration time curve of empagliflozin in plasma over time interval from 0 hours extrapolated to infinity (AUC0-8) [ Time Frame: 72 hours ]
  • maximum measured concentration of empagliflozin in plasma (Cmax) [ Time Frame: 72 hours ]
Change History Complete list of historical versions of study NCT01451775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator. [ Time Frame: Screening until end of trial, average of 45 days ]
Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Official Title  ICMJE Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects
Brief Summary Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
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: Empagliflozin
    high dose of empagliflozin after overnight fasting for at least 10 h
  • Drug: Empagliflozin
    low dose empagliflozin after overnight fasting for at least 10 h
  • Drug: Empagliflozin
    high dose of empagliflozin after a standardised high fat breakfast
Study Arms  ICMJE
  • Experimental: Treatment A
    high dose of empagliflozin after overnight fasting for at least 10 h
    Intervention: Drug: Empagliflozin
  • Experimental: Treatment B
    high dose of empagliflozin after a standardised high fat breakfast
    Intervention: Drug: Empagliflozin
  • Experimental: Treatment C
    low dose empagliflozin after overnight fasting for at least 10 h
    Intervention: Drug: Empagliflozin
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: October 11, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

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 NCT01451775
Other Study ID Numbers  ICMJE 1245.79
2011-002836-13 ( 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 June 2014

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