A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -
- Registration Number
- NCT02650063
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117 ophthalmic solution (one drop once daily for 7 days) in healthy male adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male adult volunteers
Exclusion Criteria
- Subjects with any history of severe diseases that preclude participation in this study for safety reasons
- Subjects with any diseases that preclude participation in this study for safety reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DE-117 ophthalmic solution DE-117 -
- Primary Outcome Measures
Name Time Method Elimination half-life (T1/2) 7 days Area under concentration-time curve (AUC) 7 days Maximum plasma concentration (Cmax) 7 days Time to maximum plasma concentration (Tmax) 7 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CPC Clinical Trial Hospital, Medipolis Medical Research Institute
🇯🇵Kagoshima, Japan