Healthy subjects
Conditions
Interventions
investigational material(s)
Generic name etc : S-600918
INN of investigational material : -
Therapeutic category code : 222 Antitussives
Dosage and Administration for Investigational material : Oral
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male subjects
Exclusion criteria
Exclusion criteria: Subjects who are considered ineligible for this study by the investigator or subinvestigator due to current or history of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immune, neurological or psychiatric disorders, or other clinically significant diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 half-life (t1/2,z), and terminal elimination rate constant (lambdaz), mean residence time (MRT), apparent total clearance (CL/F), and apparent volume of distribution in the terminal elimination phase (Vz/F) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Treatment-emergent adverse events (TEAEs), physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms | — |
Countries
Japan
Outcome results
None listed