Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
- Registration Number
- NCT03443960
- Lead Sponsor
- Tonix Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A (TNX-102 SL) TNX-102 SL 5.6 mg 2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days Treatment B (AMRIX) Amrix 30 mg 1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days
- Primary Outcome Measures
Name Time Method 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).
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).
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quebec City
🇨🇦Quebec City, Quebec, Canada