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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DE-117 ophthalmic solution

Group Type EXPERIMENTAL

DE-117

Intervention Type DRUG

Interventions

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DE-117

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes