Calendario›TNXP›TNX-102 SL

TNX-102 SL

A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects

Ensayo de Tonix Pharmaceuticals Holding Corp. en Healthy Subjects (HS) (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

20

previstos

Centros

1

Fin del objetivo primario

abr 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2022.

Qué mide

AUC0-∞: Area Under the curve from time zero to infinity (Total study duration for a participant is up to 72 days, which includes the screening period) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: To characterize the pharmacokinetic (PK) profile and dose proportionality of cyclobenzaprine and norcyclobenzaprine following administration of 2.8 mg and 5.6 mg of TNX-102 SL (either one or two 2.8 mg tablets) under fasting conditions in Japanese and Chinese subjects. To retrospectively compare PK data from the Japanese and Chinese study subjects with existing data from a non-Asian Phase 1 study investigating the administration of 2.8 mg and 5.6 mg of TNX-102 SL under fasting conditions. Secondary Objective: To assess the safety and tolerability of TNX-102 SL (2.8 mg and 5.6 mg) in healthy Japanese and Chinese subjects.

Más ensayos de TNXP

Todos los de TNXP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07464535), actualizada en mar 2026.