A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

Trial Profile

A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 24 May 2018

At a glance

  • Drugs Cyclobenzaprine (Primary) ; Cyclobenzaprine
  • Indications Agitation; Post-traumatic stress disorders
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Tonix Pharmaceuticals Inc
  • Most Recent Events

    • 24 May 2018 According to a Tonix Pharmaceuticals Holding Corp media release, preliminary results from this study supports the 505(b)(2) NDA submission for TNX-102 SL.
    • 24 May 2018 Preliminary results presented in a Tonix Pharmaceuticals Holding Corp Media Release.
    • 23 Apr 2018 Status changed from recruiting to completed.
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