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TNX-102 SL Tablet

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

Ensayo de Tonix Pharmaceuticals Holding Corp. en Pharmakokinetic · Open Label · Phase 1 (del registro, en inglés).

Fase

Fase 1

Estado

En marcha, sin reclutar

Participantes

50

previstos

Centros

1

Fin del objetivo primario

feb 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2025.

Qué mide

AUC0-inf: Area Under the curve from time zero to infinity (From dosing day to end of treatment at 16 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroTNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia. Fibromyalgia is a long-lasting condition that causes pain all over the body, along with feeling tired and not sleeping well. TNX-102 SL is not approved for any conditions in Canada. The study looks at the safety and blood levels of a study drug called TNX-102 SL \[cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets\], taken under the tongue, and compares it in non-elderly and elderly male and female participants.

Más ensayos de TNXP

Todos los de TNXP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07413367), actualizada en feb 2026.