A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
- Registration Number
- NCT01125657
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 44
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description formualation-A to -B sequence group YM150 - formulation-B to -A sequence group YM150 -
- Primary Outcome Measures
Name Time Method Plasma concentration of YM150 and its metabolites measured by blood sample for 3 days after drug administration
- Secondary Outcome Measures
Name Time Method Safety assessed by AEs, vital signs, 12-lead ECG and lab tests or 3 days after drug administration