A Single-Dose, Open-Label, Randomized, Parallel-Design Study of the Comparative Pharmacokinetics and Safety of TNX-102 2.4 mg SL Tablets (With Phosphate) at 2.4 mg and 4.8 mg, TNX-102-A 2.4 mg SL Tablets (Without Phosphate) at 2.4 mg and Cyclobenzaprine 5 mg Oral Tablets in Healthy Adults.

Trial Profile

A Single-Dose, Open-Label, Randomized, Parallel-Design Study of the Comparative Pharmacokinetics and Safety of TNX-102 2.4 mg SL Tablets (With Phosphate) at 2.4 mg and 4.8 mg, TNX-102-A 2.4 mg SL Tablets (Without Phosphate) at 2.4 mg and Cyclobenzaprine 5 mg Oral Tablets in Healthy Adults.

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Sep 2014

At a glance

  • Drugs Cyclobenzaprine (Primary) ; Cyclobenzaprine (Primary)
  • Indications Fibromyalgia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Tonix Pharmaceuticals Inc
  • Most Recent Events

    • 06 Jun 2013 Planned End Date changed from 1 Dec 2012 to 1 Mar 2014 as reported by ClinicalTrials.gov.
    • 23 Oct 2012 Primary endpoint 'Drug-concentration' has been met.
    • 23 Oct 2012 Status changed from active, no longer recruiting to completed, as reported in a Tonix Pharmaceuticals media release.
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