NCT04767035

Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine

A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine Under Fasted Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Melt Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers

Detailed description

A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of 2 doses of 3.5mgMELT-100, IV Midazolam, and IV Ketamine 18mg under Fasted Conditions in Healthy Volunteers

Conditions

• Procedural Sedation

Interventions

Type	Name	Description
DRUG	midazolam / ketamine sublingual tablet	sublingual tablet

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-01-14
• Completion: 2021-01-14
• First posted: 2021-02-23
• Last updated: 2021-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study