An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Inje University Busan Paik Hospital
Busan, South Korea
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Change from baseline of testosterone and DHT(ng/mL)
Time frame: day1: before administration, day7: before administration and 6, 12, 24h after administration
Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Css,min(Minimum steady state concentration)of Finasteride(ng/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
t1/2β(Elimination Half-life) of Finasteride(hr)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
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