Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713709
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2021-01-11
Brief Title:
A Single-Dose Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
Sponsor:
Nasus Pharma
Organization:
Nasus Pharma
Study Overview
Official Title:
A Single-Dose Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan 4 mg01 mL Nasal Spray Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2022-04
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 Single-Dose Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder
Detailed Description:
A comparison between FMXIN001 4 mg and Narcan 4 mg01 mL Nasal Spray under Fasting Conditions A pharmacokinetic study in healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None