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

Study Overview
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Brief Summary
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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.

Official Title
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A Multiple-Dose, Randomized, Open-Label, Parallel Pharmacokinetic Comparison Study of TNX-102 SL (Cyclobenzaprine Hydrochloride [HCl] Sublingual Tablets) 2 x 2.8 mg Versus AMRIX® (Cyclobenzaprine HCl ER Capsules) 30 mg in Healthy Subjects Under Fasting Conditions

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: TNX-102 SL 5.6 mg
* Drug: Amrix 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), with Body Mass Index (BMI) >18.5 and <30.0 kg/m2 Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study Capable of consent Exclusion Criteria: Any clinically significant abnormality or abnormal laboratory test results found during medical screening Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening History of allergic reactions to cyclobenzaprine, any of the formulation component, or other related drugs Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration Positive pregnancy test at screening Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening History of significant alcohol or drug abuse within one year prior to screening 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 Use of medication other than topical products without significant systemic absorption and hormonal contraceptives Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing. Abnormal hemoglobin and hematocrit levels at screening Breast-feeding subject Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A (TNX-102 SL)<br>2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days | Drug: TNX-102 SL 5.6 mg<br>* Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.<br>* Other names: cyclobenzaprine HCl;|
| Active Comparator: Treatment B (AMRIX)<br>1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days | Drug: Amrix 30 mg<br>* Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.<br>* Other names: cyclobenzaprine HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose). | Day 1 to Day 27 | 
| Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose). | Day 1 to Day 27 | 
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed. | Day 1 to Day 47 | 
| Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose). | Day 1 to Day 47 |