Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198686
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-12-27
Brief Title:
An Evaluation of The Absolute Bioavailability of TH104
Sponsor:
Tharimmune Inc
Organization:
Tharimmune Inc
Study Overview
Official Title:
An Evaluation of The Absolute Bioavailability of TH104
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-dose single-center open-label randomized 2-way crossover study 2 treatments 2 periods and 2 sequences of a buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection with a least 7 days washout period between doses
Detailed Description:
None
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