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

Browse trials for

• Alopecia 609
• Alopecia Areata 467

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 14 is below the median of 45 across 513 interventional studies indexed under Alopecia.

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Study arms

• Experimental
  Sequence A

  Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)

  Drug: DA-4001 H · Drug: DA-4001 L

• Experimental
  Sequence B

  Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)

  Drug: DA-4001 H · Drug: DA-4001 L

Interventions

• DrugDA-4001 H

  5% minoxidil / high dose of finasteride

• DrugDA-4001 L

  5% minoxidil / low dose of finasteride

Primary outcomes

1. 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

2. 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

3. Change from baseline of testosterone and DHT(ng/mL)

   Time frame: day1: before administration, day7: before administration and 6, 12, 24h after administration

Secondary outcomes

1. 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

2. 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

3. 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