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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Empagliflozin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01451775     History of Changes
Other Study ID Numbers: 1245.79
2011-002836-13 ( EudraCT Number: EudraCT )
First Posted: October 14, 2011    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs