Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Phase 1
Completed
- Conditions
- Ocular HypertensionGlaucoma
- Interventions
- Drug: OPC-1085EL ophthalmic solution
- Registration Number
- NCT02108288
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Subjects who are considered medically healthy per investigator's judgment
Exclusion Criteria
- Subjects with ocular conditions as defined by the protocol
- Subjects with intraocular pressure: <10 or ≥22 mmHg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPC-1085EL ophthalmic solution OPC-1085EL ophthalmic solution Once daily Carteolol long-acting ophthalmic solution Carteolol long-acting ophthalmic solution Once daily Latanoprost ophthalmic solution Latanoprost ophthalmic solution Once daily
- Primary Outcome Measures
Name Time Method Cmax of Carteolol Day 1 and Day 7 Cmax of Latanoprost Acid Day 1 and Day 7
- Secondary Outcome Measures
Name Time Method Tmax of Carteolol Day 1 and Day 7 Tmax of Latanoprost Acid Day 1 and Day 7