Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02824380

Enrollment

Registered

2016-07-06

Start date

2016-07-31

Completion date

2016-10-31

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenic Alopecia

Brief summary

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.

Interventions

DRUGDA-4001 H

5% minoxidil / high dose of finasteride

DRUGDA-4001 L

5% minoxidil / low dose of finasteride

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)	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)	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)	day1: before administration, day7: before administration and 6, 12, 24h after administration

Secondary

Measure	Time frame
Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)	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)	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)	day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026