An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects
Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2\~D6: PHP-201 0.5% topical eye drop OU TID
Inje University Busan Baek Hospital
Busan, Busanjin-gu, South Korea
Maximum Plasma Concentration [Cmax]
Cmax of PHP-201 \& Metabolite
Time frame: 1week
Time to Cmax[Tmax]
Tmax of PHP-201 \& Metabolite
Time frame: 1week
Mean Change of Intraocular pressure(IOP)
Mean Change from baseline IOP after 1week
Time frame: 1week
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