Androgenetic Alopecia
Conditions
Brief summary
To evaluate pharmacokinetics and safety of AD-208.
Detailed description
The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.
Interventions
DRUGAD-208
Dutasteride 0.2mg
DRUGAvodart Soft Capsule 0.5mg
Dutasteride 0.5mg
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male Adult aged between 19 to 50 at the time of screening visit * Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit * No evidence of medical symptoms or signs of congenital or no chronic disease
Exclusion criteria
* If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Pre-dose(0 hour) to 72 hour | Cmax of the total ingredient of dutasteride |
| Area under the curve in time plot (AUCt) | Pre-dose(0 hour) to 72 hour | AUCt of the total ingredient of dutasteride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach Cmax(Tmax) | Pre-dose(0 hour) to 72 hour | Tmax of the total ingredient of dutasteride |
| Effective half-life(t1/2) | Pre-dose(0 hour) to 72 hour | t1/2 of the total ingredient of dutasteride |
| Volume of distribution(Vd/F) | Pre-dose(0 hour) to 72 hour | Vd/F of the total ingredient of dutasteride |
| Clearance(CL/F) | Pre-dose(0 hour) to 72 hour | CL/F of the total ingredient of dutasteride |
| Area under the curve in time plot (AUCinf) | Pre-dose(0 hour) to 72 hour | AUCinf of the total ingredient of dutasteride |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | From Day -1 until Day 59 | Incidence rate of adverse events |
Countries
South Korea
Outcome results
None listed