The aim of this study is to assess the delivery of SR-T100 from the topical gel (containing 2.3% solamargine in Solanum undatum plant extract) by determining the plasma levels of solamargine in subjects with AK while administration of a 25 cm2 contiguous or non-contiguous dermal treatment area.
It is an open-label, multiple-dose, pharmacokinetic study. In stage 1, plasma concentration of solamargine will be examined after the test products were administrated to 5 subjects with Actinic Keratosis (AK). Thereafter, an interim report based on the results of stage 1 will be submitted for Taiwan Center for Drug Evaluation (CDE) review to determine stage 2 will be conducted or not. For stage 2, another 5 subjects with AK will be enrolled to complete the study. The subjects will be recruited from AK patients of Taiwan. All subjects will sign an informed consent form (ICF). A copy of the signed ICF will be handed to the subjects. The subjects will be screened on an outpatient basis within 1 month prior to entry according to defined inclusion and exclusion criteria (medical history, personal history, physical examination, and laboratory values). The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria. In the study period, study drug will be given once daily for sixteen consecutive weeks. Specifically, subjects will receive a single dose of 0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 25 cm2 skin area covered by occlusive dressing at least 20 hours a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)
National Cheng Kung University Hospital
Tainan, Taiwan
AUC0-τ,ss;
AUC0-τ,ss was determined by the area under the plasma concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule
Time frame: sixteen consecutive weeks.
AUMC0-τ,ss
AUMC0-τ,ss was determined by the area under the plasma (first) moment concentration-time curve during a dosing interval at the last dose determined by the trapezoidal rule according to the following equation: AUMC0-τ,ss = Σ\[(tn - tn-1)(Cn-1tn-1 + Cntn) /2\]
Time frame: sixteen consecutive weeks.
Cmax,ss;
Cmax,ss was determined by the the highest observed plasma concentration at steady state (the last dosing interval)
Time frame: sixteen consecutive weeks.
Cmin,ss;
Cmin,ss was determined by the minimum observed plasma concentration at steady state
Time frame: sixteen consecutive weeks.
Cave,ss
Cave,ss was determined by the average plasma concentration at steady state (the last dosing interval) according to the following equation: Cave,ss = AUCss / dosing interval
Time frame: sixteen consecutive weeks.
Fluctuation
Fluctuation was determined by the Fluctuation index of concentration at steady state
Time frame: sixteen consecutive weeks.
Tmax,ss;
Tmax,ss was determined by the time to reach highest observed plasma concentration at steady state (the last dosing interval)
Time frame: sixteen consecutive weeks.
kel
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kel was determined by the plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
Time frame: sixteen consecutive weeks.
T½;
T½ was determined by the plasma half-life estimated by (0.693/kel)
Time frame: sixteen consecutive weeks.
MRTss
MRTss was determined by the mean residence time determined by AUMC0-τ,ss / AUC0-τ,ss
Time frame: sixteen consecutive weeks.
Adverse events will be recorded to evaluate the safety outcome.
Time frame: sixteen consecutive weeks.