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To evaluate pharmacokinetics and safety of AD-208.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avodart Soft Capsule 0.5mg to AD-208 | Experimental | Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab |
|
| AD-208 to Avodart Soft Capsule 0.5mg | Experimental | Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-208 | Drug | Dutasteride 0.2mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCt) | AUCt of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| Peak Plasma Concentration (Cmax) | Cmax of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCinf) | AUCinf of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| Time to reach Cmax(Tmax) | Tmax of the total ingredient of dutasteride |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Incidence rate of adverse events | From Day -1 until Day 59 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D., Ph.D | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 41944 | 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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| Avodart Soft Capsule 0.5mg | Drug | Dutasteride 0.5mg |
|
| Pre-dose(0 hour) to 72 hour |
| Effective half-life(t1/2) | t1/2 of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| Clearance(CL/F) | CL/F of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| Volume of distribution(Vd/F) | Vd/F of the total ingredient of dutasteride | Pre-dose(0 hour) to 72 hour |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |