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

NCT01490788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-11

Study results available
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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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Denis Audet, MD · PharmaNet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-11-18
Primary Completion
2011-12-30
Completion
2011-12-30

Countries

  • Canada

Study Locations

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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 NCT01490788 on ClinicalTrials.gov