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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Huashan Hospital, Fudan University
London, China
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration
Time frame: Day 1
Maximum plasma concentration (Cmax)
Maximum plasma concentration
Time frame: 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
Time frame: Day 1
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration
Time frame: Day 7
Maximum plasma concentration at steady state (Cmax,ss)
Maximum plasma concentration at steady state
Time frame: Day 7
Minimum plasma concentration at steady state (Cmin,ss)
Minimum plasma concentration at steady state
Time frame: Day 7
AEs and SAEs
Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs), and their relevance with the investigational drug.
Time frame: Day 7
Temperature
Incidence of abnormal clinically significant temperature results.
Time frame: Day 7
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Pulse rate
Incidence of abnormal clinically significant pulse rate results.
Time frame: Day 7
Blood pressure
Incidence of abnormal clinically significant blood pressure results.
Time frame: Day 7