NCT02029066

Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: G&E Herbal Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	SR-T100 gel	2g of SR-T100 will topical apply on 100 cm\^2 once for 24 hours.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-01-07
• Last updated: 2015-08-13

Locations

1 site across 1 country: Taiwan