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Clinical trial

Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers

ID
Name
101260007LT
Description
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.
Trial arms
Trial start
2023-05-25
Estimated PCD
2023-06-21
Trial end
2023-06-21
Status
Completed
Phase
Early phase I
Treatment
STN1012600 ophthalmic solution 0.002%
1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days
Arms:
STN1012600 0.002%
Size
8
Primary endpoint
Maximum Plasma Concentration [Cmax]
1 week, Day 1 and Day 7
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}
Updated at
2023-12-05

1 organization

1 product

1 indication

Organization
Santen Pharmaceutical
Product
STN1012600
Indication
Healthy Adult Males Volunteers