Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02029066
Study type	Interventional
Source	G&E Herbal Biotechnology Co., LTD
Contact
Status	Completed
Phase	Phase 1
Start date	November 2013
Completion date	February 2014

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