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

NCT04767035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-02-23

No results posted yet for this study

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

Conditions

  • Procedural Sedation

Interventions

DRUG

midazolam / ketamine sublingual tablet

sublingual tablet

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Melt Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-01-14
Completion
2021-01-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767035 on ClinicalTrials.gov