Trials / Completed
CompletedNCT04485702
Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Melt Pharmaceuticals · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Accepted
Summary
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam injection | 2mg IV |
| DRUG | Ketamine Injectable Product | 6mg IV |
| DRUG | MELT-100 | midazolam 3mg and ketamine 25mg SL tablet |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2020-08-29
- Completion
- 2020-08-29
- First posted
- 2020-07-24
- Last updated
- 2021-02-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04485702. Inclusion in this directory is not an endorsement.