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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

NCT07413367 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-17

No results posted yet for this study

Summary

TNX-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.

Conditions

  • Pharmakokinetic
  • Open Label
  • Phase 1

Interventions

DRUG

TNX-102 SL Tablet

CYCLOBENZAPRINE HYDROCHLORIDE SUBLINGUAL TABLET

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dan Rudin, MD · Tonix Pharmaceuticals

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-02-10
Completion
2026-02-10
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413367 on ClinicalTrials.gov