Healthy subjects
Conditions
Sponsors
Eligibility
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, gastric, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematic, and other clinically important disorder and is judged as an ineligible by the investigator or subinvestigator. The subject whose family has a history of hematic disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioavailability pharmacokinetics maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-life (t1/2,z), apparent total clearance (CL/F), and mean residence time (MRT) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Adverse events (AEs), clinical laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature, and ECG parameters | — |
Countries
Japan