Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04485702
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine
Sponsor:
Melt Pharmaceuticals
Organization:
Study Overview
Official Title:
A Pilot Phase 1, Randomized, Single-Dose, 6-Sequences, 3-Period, Crossover Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual Tablet) and Intravenous Midazolam or Ketamine in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-02
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:
None
Brief Summary:
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: