Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Otsuka Pharmaceutical Co., Ltd.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Glaucoma Ocular Hypertension

Interventions

OPC-1085EL ophthalmic solutionDRUG

Carteolol long-acting ophthalmic solutionDRUG

Latanoprost ophthalmic solutionDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Kansai Region, Japan

Outcomes

Primary Outcomes

Cmax of Carteolol

Time frame: Day 1 and Day 7

Cmax of Latanoprost Acid

Time frame: Day 1 and Day 7

Secondary Outcomes

Tmax of Carteolol

Time frame: Day 1 and Day 7

Tmax of Latanoprost Acid

Time frame: Day 1 and Day 7

Data from ClinicalTrials.gov

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