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SL TNX-102 2.4 mg at pH 3.5

Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

Ensayo de Tonix Pharmaceuticals Holding Corp. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

24

previstos

Centros

1

Fin del objetivo primario

sep 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2012.

Qué mide

• Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine (27 time points per period for blood assessment ; 3 pooled analyses in urine.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroVery low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).

Más ensayos de TNXP

Todos los de TNXP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01634412), actualizada en sep 2014.