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The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clascoterone Cream 1% | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clascoterone Cream 1% | Drug | Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Time to maximum plasma concentration | Day 1 |
| Maximum plasma concentration (Cmax) | Maximum plasma concentration | Day 1 |
| Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t) | Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration | Day 1 |
| Time to maximum plasma concentration (Tmax) | Time to maximum plasma concentration | Day 7 |
| Maximum plasma concentration at steady state (Cmax,ss) | Maximum plasma concentration at steady state | Day 7 |
| Minimum plasma concentration at steady state (Cmin,ss) | Minimum plasma concentration at steady state | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs | Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs), and their relevance with the investigational drug. | Day 7 |
| Temperature | Incidence of abnormal clinically significant temperature results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | London | N1 9JP | China |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Day 7 |
| Pulse rate | Incidence of abnormal clinically significant pulse rate results. | Day 7 |
| Blood pressure | Incidence of abnormal clinically significant blood pressure results. | Day 7 |