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| ID | Type | Description | Link |
|---|---|---|---|
| 1025023899 | Other Identifier | TFDA |
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This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded.
In the study period, a single dose of 2 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. Sampling Time Schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR-T100 gel | Experimental | dosage form: topical gel dosage: 2g of 2.3% SR-T100 frequency: once duration: 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR-T100 gel | Drug | 2g of SR-T100 will topical apply on 100 cm^2 once for 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the delivery of SR-T100 from the topical gel by determining the plasma solamargine levels in subjects with AK within a 100 cm^2 treatment area. | Twelve Subjects will participate in this study. Each patient will be taken blood samples (6 ml for each) before and after applying of SR-T100 at 0, 0.5, 1, 1.5, 2,2.5, 3, 4, 5, 6, 8, 10,12,16, 20, 24, 28, 34, and 36 hour. Plasma solamargine will be analyzed from blood samples using a bioanalytical method. Pharmacokinetic parameters such as AUC0-t, AUC0-infinity, Cmax Tmax, T½, λz, clearance and MRT will be calculated from plasma concentrations of solamargine and presented in the final report. | 33 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate. | Medical history: medical and personal histories will be evaluated by investigators in order to determine whether the subject fulfills the inclusion/exclusion criteria. Clinical examinations: vital signs and physical examinations. Blood pressure, heart rate, body temperature in the sitting position, body weight, and height will be measured. Laboratory tests: Hematology (Hemoglobin, hematocrit, WBC count with differential, RBC count, and platelet count), Biochemistry (Total protein, SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine, uric acid, total cholesterol, and TG), Urinalysis (Specific gravity, ketone body, urine bilirubin, urobilinogen, leukocyte, nitrite, pH, occult blood, glucose, and protein), Serology (Anti-HIV test, HBsAg and Anti-HCV), and Pregnancy test (Urine or serum pregnancy test (for female patients with childbearing potential)). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamm-Ming Sheu, M.D. | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| 33 days and 7 days follow up period after complete study. |
| D017437 |
| Skin and Connective Tissue Diseases |