NCT03443960

Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride \[HCl\] extended-release \[ER\] capsules), 30 mg.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TNX-102 SL 5.6 mg	Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
DRUG	Amrix 30 mg	Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.

Timeline

• Start date: 2018-01-29
• Primary completion: 2018-04-09
• Completion: 2018-04-09
• First posted: 2018-02-23
• Last updated: 2018-04-24

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study