Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Seoul National University Hospital
Seoul, South Korea
RECRUITINGAUC 0-t
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Cmax
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
AUC 0-8h, AUC 0-168h, AUCinf
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
CL/F, Vd/F
Clearance, Volume of distribution
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Tmax, t½
Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
Frel
Relative bioavailability compared to the active control
Time frame: Pre-dose (0 hour) up to 672 hours post-dose
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placebo microneedle patch