Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
Phase 1
Completed
- Conditions
- Healthy Adult Males Volunteers
- Interventions
- Drug: STN1012600 ophthalmic solution 0.002%
- Registration Number
- NCT05905653
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STN1012600 0.002% STN1012600 ophthalmic solution 0.002% -
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration [Cmax] 1 week, Day 1 and Day 7 Calculate plasma pharmacokinetic parameters and study pharmacokinetics.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Medical Corporation Heishinkai OPHAC Hospital
🇯🇵Osaka, Japan