Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Not Applicable
Completed
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0001989
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
Male, aged between 19 and 65 years, clinically healthy
-BMI between 18.5kg/m2 and 27kg/m2
-Clinical history of Androgenic Alopecia
Exclusion Criteria
-Subject has any dermatological disorders of the scalp
-Subject has a history of hair transplants, hair weaves
-Subject has hypersensitivity to previously prescribed minoxidil or finasteride
-Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameter: Css,max(maximum steady state concentration) of finasteride (ng/mL) ;PK parameter: AUCtau(area under the plasma concentration versus time curve) of finasteride (ng·hr/mL);PD parameter: Change from baseline of testosterone and DHT(Dihydrotestosterone) (ng/mL)
- Secondary Outcome Measures
Name Time Method PK parameter: Css,min(minimum steady state concentration) of finasteride (ng/mL);PK parameter: t1/2ß(elimination half-life) of finasteride (hr);PK parameter: Tss,max(Time to reach maximal serum concentrations at steady state) of finasteride (hr)