Tonix Receives FDA Approval to Initiate TNX-102 Study
About 30 healthy adult volunteers will be enrolled in the single-dose, open-label, randomised and three-way crossover study.
US specialty pharmaceutical company Tonix Pharmaceuticals has received FDA approval to initiate a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation of cyclobenzaprine for the treatment of fibromyalgia.
TNX-102 is a gelcap containing very low dose cyclobenzaprine, designed for faster and improved absorption relative to conventional cyclobenzaprine products.
About 30 healthy adult volunteers will be enrolled in the single-dose, open-label, randomised and three-way crossover study, which will compare a TNX-102 candidate gelcap containing 2.4mg of cyclobenzaprine to a 5mg cyclobenzaprine tablet.
Additionally, the study will assess the effect of food on the pharma
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