Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-04 @ 12:54 PM
Study NCT ID:
NCT02029066
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
Sponsor:
G&E Herbal Biotechnology Co., LTD
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1025023899 | OTHER | TFDA | View |