A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
NCT ID: NCT00965978
Last Updated: 2009-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-07-31
2009-09-30
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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Low dose group
Receives low dose of ONO-5920/YM529 with and without food
ONO-5920 / YM529
oral
High dose group
Receives high dose of ONO-5920/YM529 with and without food
ONO-5920 / YM529
oral
Interventions
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ONO-5920 / YM529
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight: more than 40.0 Kg and less than 70.0 Kg
* BMI: more than 17.6 and less than 30.0
Exclusion Criteria
* Blood donation before the study
* With abnormal laboratory values
45 Years
81 Years
FEMALE
Yes
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma, Inc
Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Kantou, , Japan
Countries
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Other Identifiers
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529-CL-027
Identifier Type: -
Identifier Source: org_study_id
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