NCT01889173 is a Phase 1 clinical trial of TNX-102 SL Tablets at 2.8 mg in Healthy Adults, sponsored by Tonix Pharmaceuticals, Inc..

Who is sponsoring NCT01889173?

NCT01889173 is sponsored by Tonix Pharmaceuticals, Inc..

What drugs are being tested in NCT01889173?

Interventions in NCT01889173: TNX-102 SL Tablets at 2.8 mg, TNX-102-B SL Tablets at 2.8 mg, TNX-102-C SL Tablets at 2.8 mg, Cyclobenzaprine tablets.

What condition does NCT01889173 study?

NCT01889173 studies Healthy Adults.

Is NCT01889173 still recruiting?

NCT01889173 is currently completed. Last updated 24 September 2014.

Last reviewed 2014-09-24 · How we verify

NCT01889173

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single-Dose, Open-Label, Randomized, Parallel-Design Study Of The Comparative Pharmacokinetics And Safety Of TNX-102 2.8 mg SL Tablets (With Potassium Phosphate) At 2.8 mg, TNX-102-B 2.8 mg SL Tablets (With Sodium Phosphate) At 2.8 mg, TNX-102-C 2.8 mg SL Tablets (With Trisodium Citrate) At 2.8 mg, And Cyclobenzaprine 5 mg Oral Tablets In Healthy Adults

Completed Phase 1 Last updated 24 September 2014

What this trial tests

Phase 1 trial testing TNX-102 SL Tablets at 2.8 mg in Healthy Adults in 24 participants. Completed in 1 March 2014.

Timeline

1 June 2013

Primary endpoint
1 December 2013

1 March 2014

Quick facts

Lead sponsor	Tonix Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 June 2013
Primary completion	1 December 2013
Estimated completion	1 March 2014
Sites	1 location across Canada

Drugs / interventions tested

TNX-102 SL Tablets at 2.8 mg — full drug profile →
TNX-102-B SL Tablets at 2.8 mg — full drug profile →
TNX-102-C SL Tablets at 2.8 mg — full drug profile →
Cyclobenzaprine tablets — full drug profile →

Conditions studied

Healthy Adults — all drugs for Healthy Adults →

Sponsor

Tonix Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Adults. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
Time frame: 26 time points per period for blood assessment ; 2 pooled analyses in urine.
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24 and 24-48 hours post-dose.
Safety and tolerability of the 3 formulations of TNX-102 SL Tablets at 2.8 mg
Time frame: Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)
Every adverse events occurring during the study period will be reported.

Sponsor's own description

Very 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers.
Daugherty BL, Meibohm B, Sullivan GM, Gould EM, et al · · 2026 · PMID 41749492 · DOI 10.1002/cpdd.70034

Verify or expand the search:

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Other Tonix Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07413367 — A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine · Phase 1 · active not recruiting
NCT06045793 — Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (C · Phase 2 · terminated
NCT07473752 — A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, · Phase 1 · completed
NCT05686408 — Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) · Phase 2 · completed
NCT05679908 — A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01889173 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc.
Last refreshed: 24 September 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01889173.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing