NCT04164719

Dose-Proportionality and Food Effect Study of TNX-102 SL

A Single-dose, Randomized, Open-label, 3-way Crossover Study to Evaluate the Dose-proportionality and Food Effect of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TNX-102 SL	Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them

Timeline

• Start date: 2019-10-14
• Primary completion: 2019-12-24
• Completion: 2019-12-24
• First posted: 2019-11-15
• Last updated: 2020-01-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study