MedTrace Logo

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

NCT03443960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2018-04-09
Completion
2018-04-09
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443960 on ClinicalTrials.gov