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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose) |
|
| Sequence B | Experimental | Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-4001 H | Drug | 5% minoxidil / high dose of finasteride |
| |
| Measure | Description | 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 |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| DA-4001 L |
| Drug |
5% minoxidil / low dose of finasteride |
|
| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |