A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet
NCT ID: NCT01125670
Last Updated: 2010-05-25
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
24 participants
INTERVENTIONAL
2010-02-28
2010-04-30
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
NONE
Study Groups
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fast-fed sequence group
YM150
oral
fed-fast sequence group
YM150
oral
Interventions
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YM150
oral
Eligibility Criteria
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Inclusion Criteria
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
Exclusion Criteria
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 7 days before the study
* A deviation from the assessment criteria of physical examinations or laboratory tests
* A deviation from the normal reference range of coagulation test \[PT (INR) or aPTT\]
* History of drug allergies
* Upper gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Concurrent or previous malignant tumor
* Previous treatment with YM150
20 Years
44 Years
MALE
Yes
Sponsors
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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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Kyushu, , Japan
Countries
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Other Identifiers
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150-CL-047
Identifier Type: -
Identifier Source: org_study_id
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