Healthy subjects
Conditions
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy adult male subjects between the ages >=20 and <40
Exclusion criteria
Exclusion criteria: The subject who has a history of nervous, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematic and other clinically important disorder and were considered ineligible by the investigator or subinvestigator. Subjects whose family has a history of thrombosis, coagulation disorder, or thrombocytosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioavailability pharmacokinetics maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last), area under the concentration-time curve extrapolated from time zero to infinity (AUC0-inf), terminal elimination rate constant (lambdaz), terminal elimination half-life (t1/2,z), apparent total clearance (CL/F), and mean residence time (MRT). | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Vital signs, electrocardiograms, clinical laboratory tests, and adverse events (AEs). | — |
Countries
Japan
Outcome results
None listed