Status:
COMPLETED
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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® (c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03443960
Start Date
January 29 2018
End Date
April 9 2018
Last Update
April 24 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quebec City
Québec, Quebec, Canada, G1P 0A2