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
← catalyst calendarSponsored by Tonix Pharmaceuticals, Inc. (industry) · TNXP — their whole pipeline →. With Syneos Health.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Basic science
Enrollment
50actual
Sites
1
Country
Canada
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-09 | actual | When the study began enrolling |
| Primary completion | 2026-02-10 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-10 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pharmakokinetic
- Open Label
- Phase 1
Intervention
- Drug: TNX-102 SL Tablet
Primary outcomes
what the primary-completion date above is the date OFAUC0-inf: Area Under the curve from time zero to infinity
measured From dosing day to end of treatment at 16 days
AUC0-t: Area Under the Curve from time zero to the last measurable concentration
measured From dosing day to end of treatment at 16 days
Cmax: Maximum Plasma Concentration
measured From dosing day to end of treatment at 16 days
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