A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet
- Registration Number
- NCT01125670
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.
- Detailed Description
To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
Read More
Exclusion Criteria
- Received any investigational drugs within 120 days before the study
- 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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description fast-fed sequence group YM150 - fed-fast sequence group YM150 -
- Primary Outcome Measures
Name Time Method Plasma concentration of YM150 and its metabolites measured by blood samples for 3 days after drug administration
- Secondary Outcome Measures
Name Time Method Safety assessed by AEs, vital signs, 12-lead ECG and lab tests for 3 days after drug administration