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A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects

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Trial Profile

A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 May 2020

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Agitation; Alcoholism; Fibromyalgia; Post-traumatic stress disorders
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Tonix Pharmaceuticals Inc

Most Recent Events

  • 21 May 2020 According to a Tonix Pharmaceuticals Holding Corp media release, data from this trial will be presented at the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting to be held online virtually on May 29-30, 2020.
  • 24 Jan 2020 According to an Tonix Pharmaceuticals Holding Corp media release, the company announced that it has completed the required fed-fasting and dose proportionality tests of TNX-102 SL in healthy volunteers to support the New Drug Application (NDA) of TNX-102 SL for the treatment of posttraumatic stress disorder (PTSD) and fibromyalgia.
  • 24 Jan 2020 Results published in the Tonix Pharmaceuticals Holding Corp Media Release.

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