NCT01490788

A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Detailed description

Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A	TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
DRUG	Treatment B	Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
DRUG	Treatment C	TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Timeline

• Start date: 2011-11-18
• Primary completion: 2011-12-30
• Completion: 2011-12-30
• First posted: 2011-12-13
• Last updated: 2019-09-11
• Results posted: 2018-11-02

Locations

1 site across 1 country: Canada