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
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Healthy |
Intervention |
Drug: Empagliflozin |
Enrollment | 18 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments. |
Arm/Group Title | Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted | Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed | Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted | Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted | Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed | Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted |
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Patients were administered three treatments in the following order:
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Patients were administered three treatments in the following order:
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Patients were administered three treatments in the following order:
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Patients were administered three treatments in the following order:
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Patients were administered three treatments in the following order:
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Patients were administered three treatments in the following order:
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Period Title: Overall Study | ||||||
Started | 3 | 3 | 3 | 3 | 3 | 3 |
Completed | 3 | 3 | 3 | 3 | 3 | 3 |
Not Completed | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Study Overall | |
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Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments. | |
Overall Number of Baseline Participants | 18 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | |
36.1 (7.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | |
Female |
9 50.0%
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Male |
9 50.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Boehringer Ingelheim Call Center |
Organization: | boehringer Ingelheim Pharmaceuticals |
Phone: | 1-800-243-0127 |
EMail: | clintriage.rdg@boehringer-ingelheim.com |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01451775 |
Other Study ID Numbers: |
1245.79 2011-002836-13 ( EudraCT Number: EudraCT ) |
First Submitted: | October 11, 2011 |
First Posted: | October 14, 2011 |
Results First Submitted: | May 16, 2014 |
Results First Posted: | June 27, 2014 |
Last Update Posted: | June 27, 2014 |