Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
NCT ID: NCT01426958
Last Updated: 2014-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-08-31
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
1 tablet afatinib single dose
afatinib
standard therapeutic dose
treatment B
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
ritonavir + afatinib
simultaneous intake of ritonavir and afatinib on second treatment day
treatment C
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
ritonavir + afatinib
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
Interventions
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afatinib
standard therapeutic dose
ritonavir + afatinib
simultaneous intake of ritonavir and afatinib on second treatment day
ritonavir + afatinib
on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
MALE
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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1200.151.1 Boehringer Ingelheim Investigational Site
Biberach, , Germany
Countries
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Other Identifiers
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2011-001803-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.151
Identifier Type: -
Identifier Source: org_study_id
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