Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
NCT ID: NCT01371006
Last Updated: 2015-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BI201335 low dose Efavirenz
low dose Efavirenz
low dose
Efavirenz single dosing once daily
BI201335 high dose Efavirenz
normal dose Efavirenz
low dose
efavirenz single dosing once daily
normal dose
efavirenz once daily
Interventions
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low dose
efavirenz single dosing once daily
normal dose
efavirenz once daily
low dose
Efavirenz single dosing once daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Active diseases
3. History of photosensitivity or rash
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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1220.20.41001 Boehringer Ingelheim Investigational Site
Basel, , Switzerland
Countries
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Other Identifiers
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1220.20
Identifier Type: -
Identifier Source: org_study_id
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