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TNX-102 SL Tablets at 2.8 mg

Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

Ensayo de Tonix Pharmaceuticals Holding Corp. en Voluntarios sanos.

Fase: Fase 1
Estado: Completado
Participantes: 24
Centros: 1
Fin del objetivo primario: dic 2013

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2013.

Qué mide

Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine (26 time points per period for blood assessment ; 2 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 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).

Más ensayos de TNXP

Ensayo	Fase	Estado	Lectura de resultados
TNX-102 SL Tablet	Fase 1	En marcha, sin reclutar	feb 2026 (prevista, ya pasada: sin actualizar en el registro)
TNX-102 SL · HORIZON	Fase 2	Reclutando pacientes	feb 2028 (prevista)
TNX-1300 · CATALYST	Fase 2	Interrumpido	abr 2025 (real)
TNX-1500	Fase 1	Completado	feb 2024 (real)
TNX-102 SL Tablet · RESILIENT	Fase 3	Completado	nov 2023 (real)
TNX-1900 · PREVENTION	Fase 2	Completado	oct 2023 (real)

Todos los de TNXP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01889173), actualizada en sep 2014.