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Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

NCT ID: NCT05905653

Last Updated: 2023-12-05

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2023-06-21

Brief Summary

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To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.

Detailed Description

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Conditions

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Healthy Adult Males Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STN1012600 0.002%

Group Type EXPERIMENTAL

STN1012600 ophthalmic solution 0.002%

Intervention Type DRUG

1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days

Interventions

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STN1012600 ophthalmic solution 0.002%

1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol

Exclusion Criteria

* Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
* Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Corporation Heishinkai OPHAC Hospital

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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101260007LT

Identifier Type: -

Identifier Source: org_study_id