Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00720018
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2008-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers
Sponsor:
NuPathe Inc.
Organization:
Study Overview
Official Title:
A Phase I, Single Center, Open Label, Single-Dose, Five-Period Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-02
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:
NP101-006
Brief Summary:
The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
Detailed Description:
None
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?: