Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers
NCT ID: NCT01284621
Last Updated: 2014-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2011-01-31
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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BI 10773
1 tablet per days for 5 days, oral administration with 240 mL water for each treatment
BI 10773
medium dose oral administration
Ramipril
1 tablet on day 1 and 2 tablets per day on day 2-5, oral administration with 240 mL water for each treatment
Ramipril
Low dose oral administration on day 1
Ramipril
Medium dose oral administration on day 2-5
BI 10773 + Ramipril
1 tablet BI 10773 and 1 tablet on day 1 and 2 tablets ramipril per day on day 2-5, oral administration with 240 mL water for each treatment
BI 10773
medium dose, oral administration
Ramipril
Medium dose oral administration on day 2-5
Ramipril
Low dose oral administration on day 1
Interventions
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BI 10773
medium dose, oral administration
Ramipril
Medium dose oral administration on day 2-5
BI 10773
medium dose oral administration
Ramipril
Low dose oral administration on day 1
Ramipril
Low dose oral administration on day 1
Ramipril
Medium dose oral administration on day 2-5
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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1245.45.1 Boehringer Ingelheim Investigational Site
Biberach, , Germany
Countries
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References
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Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.
Other Identifiers
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2010-022717-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245.45
Identifier Type: -
Identifier Source: org_study_id
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