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

NCT04485702 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-02-23

No results posted yet for this study

Summary

Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

Midazolam injection

2mg IV

DRUG

Ketamine Injectable Product

6mg IV

DRUG

MELT-100

midazolam 3mg and ketamine 25mg SL tablet

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Melt Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Cynthia Zamora, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2020-08-29
Completion
2020-08-29
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 NCT04485702 on ClinicalTrials.gov