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OpenTrials
Completed

NCT Number: NCT05905653

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

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.

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Key information

Conditions

Healthy Adult Males Volunteers

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STN1012600 ophthalmic solution 0.002%

Drug

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

Primary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: 1 week, Day 1 and Day 7

    Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

Secondary outcomes

  1. Area Under The Curve From Time Zero to the Last Sampling Time [AUC 0-t]

    Time frame: 1 week, Day 1 and Day 7

    Calculate plasma pharmacokinetic parameters and study pharmacokinetics.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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