Healthy Subjects
Conditions
Brief 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.
Interventions
Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
DRUGAmrix 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
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Day 1 to Day 27 | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose). |
| Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Day 1 to Day 27 | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose). |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Day 1 to Day 47 | TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed. |
| Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg | Day 1 to Day 47 | Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose). |
Countries
Canada
Outcome results
None listed