Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
Study NCT ID:
NCT06205134
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2023-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability of Intranasal Epinephrine
Sponsor:
Nasus Pharma
Organization:
Study Overview
Official Title:
A Study to Compare the Bioavailability of Epinephrine Following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6mg, and 4mg With EpiPen 0.3mg Intramuscular Injection in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2024-03
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:
A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6 mg, and 4mg with EpiPen 0.3mg Intramuscular Injection in Healthy Adults
Detailed Description:
An open-label trial in 12 healthy adults. FMXIN002 (3.6 mg and 4.0 mg) will be administered intranasally to healthy adults and compared to IM (0.3mg, EpiPen) by Epinephrine pharmacokinetics, pharmacodynamic response and clinical safety.
(https://my.health.gov.il/CliniTrials/Pages/MOH\_2023-07-01\_012776.aspx.)
(https://my.health.gov.il/CliniTrials/Pages/MOH\_2023-07-01\_012776.aspx.)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: