A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -

Santen Pharmaceutical Co., Ltd.14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Male Adults

Interventions

DE-117DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CPC Clinical Trial Hospital, Medipolis Medical Research Institute

Kagoshima, Japan

Outcomes

Primary Outcomes

Area under concentration-time curve (AUC)

Time frame: 7 days

Maximum plasma concentration (Cmax)

Time frame: 7 days

Time to maximum plasma concentration (Tmax)

Time frame: 7 days

Elimination half-life (T1/2)

Time frame: 7 days

Data from ClinicalTrials.gov

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