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

Santen

Status and phase: Completed; Phase 1

Conditions: Healthy Male Adults

Treatments: Drug: DE-117

Study type: Interventional

Funder types: Industry

Identifiers

NCT02650063

01171502

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

DE-117 ophthalmic solution

Experimental group

Treatment:

Drug: DE-117