Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04485702 | Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine | PHASE1 | COMPLETED | 17 | — | — | Jul 20, 2020 | Aug 29, 2020 | Feb 23, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| MELT-100 | ACTIVE_COMPARATOR | 3mg midazolam and 25mg ketamine sublingual tablet |
| IV midazolam | ACTIVE_COMPARATOR | 2mg Intravenous midazolam |
| IV ketamine | ACTIVE_COMPARATOR | 6mg Intravenous ketamine |
| Name | Type | Description |
|---|---|---|
| Midazolam injection | DRUG | 2mg IV |
| Ketamine Injectable Product | DRUG | 6mg IV |
| MELT-100 | DRUG | midazolam 3mg and ketamine 25mg SL tablet |
Inclusion Criteria: * A subject must satisfy all of the following criteria to be eligible for study participation: 1. Able to understand and voluntarily consent to participation in this study, and provides written informed consent before the start of any study-specific procedures. 2. Healthy a...