Status:
COMPLETED
A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy Volunteer
Pharmacokinetics of YM178
Eligibility:
All Genders
20-54 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.
Eligibility Criteria
Inclusion
- Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests
- 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
- Received any investigational drugs within 120 days before the screening test
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00965926
Start Date
July 1 2009
End Date
September 1 2009
Last Update
July 17 2013
Active Locations (1)
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1
Kantou, Japan