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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01451775
First received: October 11, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Empagliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Boehringer Ingelheim:

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

    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 ] [ Designated as safety issue: No ]

    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.



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


Enrollment: 18
Study Start Date: October 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
high dose of empagliflozin after overnight fasting for at least 10 h
Drug: Empagliflozin
high dose of empagliflozin after overnight fasting for at least 10 h
Experimental: Treatment B
high dose of empagliflozin after a standardised high fat breakfast
Drug: Empagliflozin
high dose of empagliflozin after a standardised high fat breakfast
Experimental: Treatment C
low dose empagliflozin after overnight fasting for at least 10 h
Drug: Empagliflozin
low dose empagliflozin after overnight fasting for at least 10 h

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  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: NCT01451775

Locations
Germany
1245.79.1 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: NCT01451775     History of Changes
Other Study ID Numbers: 1245.79, 2011-002836-13
Study First Received: October 11, 2011
Results First Received: May 16, 2014
Last Updated: June 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 19, 2014