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.
NCT ID: NCT01451775
Last Updated: 2014-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment A
high dose of empagliflozin after overnight fasting for at least 10 h
Empagliflozin
high dose of empagliflozin after overnight fasting for at least 10 h
Treatment B
high dose of empagliflozin after a standardised high fat breakfast
Empagliflozin
high dose of empagliflozin after a standardised high fat breakfast
Treatment C
low dose empagliflozin after overnight fasting for at least 10 h
Empagliflozin
low dose empagliflozin after overnight fasting for at least 10 h
Interventions
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Empagliflozin
high dose of empagliflozin after overnight fasting for at least 10 h
Empagliflozin
low dose empagliflozin after overnight fasting for at least 10 h
Empagliflozin
high dose of empagliflozin after a standardised high fat breakfast
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1245.79.1 Boehringer Ingelheim Investigational Site
Biberach, , Germany
Countries
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Other Identifiers
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2011-002836-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245.79
Identifier Type: -
Identifier Source: org_study_id
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