Clinical TrialID 7188
Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
NCT02029066
Actinic Keratosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7188
- Evidence Id
- 7188
- Core Evidence Id
- 7188
- Source Clinical Trial Id
- 7177
- Herb2 Clinical Trial Id
- HBCT007177
- Nct Id
- NCT02029066
- Title
- Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Actinic Keratosis
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
- Intervention
- DRUG: SR-T100 gel
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 2
- Outcome Measure
- 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
- Sponsor Collaborator
- G&E Herbal Biotechnology Co., LTD
- Funded By
- INDUSTRY
- Location
- National Cheng Kung University Hospital, Tainan, 70403, Taiwan
- Other Id
- GESRTAKC|1025023899
- Start Date
- 2013-11
- Primary Completion Date
- 2014-02
- Completion Date
- 2014-02
- First Posted
- 2014-01-07
- Results First Posted
- Last Update Posted
- 2015-08-13
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02029066
- Title Cn
- Title En
- Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
- Bilingual Status
- semi_complete