Clinical trial NCT03443960: Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
timeFrame: Day 1 to Day 27
measure: Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
timeFrame: Day 1 to Day 27
measure: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg
timeFrame: Day 1 to Day 47
measure: Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg
timeFrame: Day 1 to Day 47
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Quebec City
state: Quebec
Study officials:
References: