A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
NCT ID: NCT00965926
Last Updated: 2013-07-17
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
72 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
NONE
Study Groups
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Low dose group
3 way cross-over. Fasting, normal diet and high-fat diet
YM178
oral
High dose group
3 way cross-over. Fasting, normal diet and high-fat diet
YM178
oral
Interventions
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YM178
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight (at screening); female ≥40.0 kg, \<70.0 kg, male ≥50.0 kg, \<80.0 kg
* BMI (at screening): ≥17.6, \<26.4
* Written informed consent has been obtained
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 screening test
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
20 Years
54 Years
ALL
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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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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178-CL-078
Identifier Type: -
Identifier Source: org_study_id
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