Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784728
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2021-03-03
Brief Title:
Pharmacokinetics and Adhesion of Lidocaine Topical System 18 With Water Exposure
Sponsor:
Scilex Pharmaceuticals Inc
Organization:
Scilex Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Open Label Randomized Three-treatment Three-sequence Three-period Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 18 in Healthy Adult Subjects Under Normal and Two Water Stress Conditions
Status:
COMPLETED
Status Verified Date:
2021-03
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:
The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido lidocaine topical system 18 during swimming showering and under normal conditions
Detailed Description:
In this Phase 1 open-label three-period crossover study 24 healthy adult male and female subjects are randomized to 1 of 3 treatment sequences During each treatment period subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments In each treatment period the subject will either swim Treatment A shower Treatment B or refrain from these activities Treatment C while wearing the topical system Blood samples for lidocaine PK will be collected pre-dose until 24 hours Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None