Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 8:27 AM
Study NCT ID:
NCT02667106
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Pharmacokinetic Study of RX0041-2
Sponsor:
Pharmaceutical Project Solutions, Inc.
Organization:
Study Overview
Official Title:
Systemic Pharmacokinetics of Acute, Topical, Intranasal Administration of RX0041-002 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2016-01
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 Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers.
Detailed Description:
This is a Phase I, single dose, single-center, open-label study of the plasma and urinary pharmacokinetics of RX004-002 and its major metabolites in male and female healthy subjects.
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?: