Healthy Adult Males Volunteers
Conditions
Brief summary
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.
Interventions
1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol
Exclusion criteria
* Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective * Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | 1 week, Day 1 and Day 7 | Calculate plasma pharmacokinetic parameters and study pharmacokinetics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t] | 1 week, Day 1 and Day 7 | Calculate plasma pharmacokinetic parameters and study pharmacokinetics. |
Countries
Japan
Outcome results
None listed