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Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03168022
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Brief Summary:
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. This bioequivalence study will confirm (1) the drug product manufactured from these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.

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

Detailed Description:

This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period, 2 sequence, crossover study under fasting conditions.

Potential subjects will be screened by medical and psychiatric history, and laboratory and physical examinations 2 to 30 days prior to drug administration. All eligible subjects will be admitted to the study unit on Day -1, the day prior to dose administration. Baseline values will be considered the last value obtained before dosing for each assessment. On Day 1, the morning after admission, after all pre-dose assessments have been completed and subjects who remain eligible have agreed to continue, subjects will be randomly assigned to study medication and will receive the assigned test drug. Subjects will be required to fast for at least 10 hours prior to dosing until at least 4 hours post-dose.

For each period, subjects will be confined to the study site from at least 10 hours before dosing until after the 24-hour post-dose blood draw. Subjects will come back for all subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : January 26, 2016
Actual Study Completion Date : January 26, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment A
1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
Drug: Treatment A
1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
Other Name: cyclobenzaprine HCl

Experimental: Treatment B
1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Drug: Treatment B
1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Other Name: cyclobenzaprine HCl

Primary Outcome Measures :
  1. Mean Plasma Concentration (AUC) of Cyclobenzaprine [ Time Frame: 0 to 96 hours ]
    Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.

  2. Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions. [ 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) ]
    The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy male or female between 18 and 65 years of age, non-smoker.
  2. Body mass index >18.5 and <30.0 kg/m2
  3. Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study.
  4. Capable of consent.

Exclusion Criteria:

  1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening
  2. Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening.
  3. History of hypersensitivity to cyclobenzaprine, any of the formulation component, or other related drugs.
  4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
  5. Positive pregnancy test at screening.
  6. Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening.
  7. History of significant alcohol or drug abuse within one year prior to screening
  8. Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
  9. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
  10. Breast-feeding subject.
  11. Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue.

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 identifier (NCT number): NCT03168022

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InVentiv Health Clinique Inc.
Quebec, Canada, GIP )A2
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
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Principal Investigator: Denis Audet, MD inVentiv

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Responsible Party: Tonix Pharmaceuticals, Inc. Identifier: NCT03168022     History of Changes
Other Study ID Numbers: TNX-CY-F105
First Posted: May 30, 2017    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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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
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents