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

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ClinicalTrials.gov Identifier: NCT01490788
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : November 2, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment A Drug: Treatment B Drug: Treatment C Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 18, 2011
Actual Primary Completion Date : December 30, 2011
Actual Study Completion Date : December 30, 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment A
1 x TNX-102 2.4 mg gelcap under fasting conditions
 Drug: Treatment A
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
Other Name: cyclobenzaprine HCl
Experimental: Treatment B
1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions
 Drug: Treatment B
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
Other Name: cyclobenzaprine HCl
Active Comparator: Treatment C
1 x TNX-102 2.4 mg gelcap under fed conditions
 Drug: Treatment C
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Other Name: cyclobenzaprine HCl


Outcome Measures
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Primary Outcome Measures :
  1. Mean Plasma Concentration (AUC) of Cyclobenzaprine [ Time Frame: 0 to 96 hours ]
    Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.

  2. Incidences of Adverse Events [ Time Frame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month) ]
    Every adverse events occurring during the study period will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Healthy adults

  • Male or female
  • Non-smoker
  • 18-55 years old
  • BMI > 18.5 and < 30.0
  • With medically acceptable form of contraception (female only).

Exclusion Criteria:

  • Any clinically significant abnormality or vital sign abnormalities
  • Any abnormal laboratory test
  • History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
  • Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
  • Positive pregnancy test, breastfeeding or lactating
  • Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
  • Participation in an investigational study within 30 days prior to dosing
  • Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490788


Locations
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Canada, Quebec
PharmaNet, Inc.
Québec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Denis Audet, MD PharmaNet
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01490788    
Other Study ID Numbers: TNX-CY-F101
First Posted: December 13, 2011    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: September 11, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Amitriptyline
Cyclobenzaprine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
 Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents