Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
|ClinicalTrials.gov Identifier: NCT02029066|
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: SR-T100 gel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: SR-T100 gel
dosage form: topical gel dosage: 2g of 2.3% SR-T100 frequency: once duration: 24 hours
Drug: SR-T100 gel
2g of SR-T100 will topical apply on 100 cm^2 once for 24 hours.
- 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. [ Time Frame: 33 days ]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.
- Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate. [ Time Frame: 33 days and 7 days follow up period after complete study. ]
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)).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029066
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 70403|
|Principal Investigator:||Hamm-Ming Sheu, M.D.||National Cheng-Kung University Hospital|