Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine

This pilot Phase I, randomized, single-dose, 6-sequences, 3-period, crossover bioavailability study (n=17) of MELT-100 (midazolam and ketamine sublingual tablet) and intravenous midazolam or ketamine in healthy volunteers has been completed.

The study, sponsored by Melt Pharmaceuticals and conducted at Worldwide Clinical Trials, aimed to compare the bioavailability of MELT-100 with intravenous midazolam or ketamine in healthy volunteers. A total of 17 participants were enrolled in the study, which began on July 20, 2020, and concluded on August 29, 2020.

The study assessed various pharmacokinetic parameters, including peak plasma concentration (Cmax), area under the plasma concentration versus time curve (AUC), and time to peak plasma concentration (Tmax). Cynthia Zamora, MD, from Worldwide Clinical Trials served as the principal investigator for the study. No publications related to the study are available at this time.

Topic Healthy Subjects
Compound Ketamine
Country United States of America
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