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

• Status: Completed
• Trial end date: 2018-04-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Amitriptyline; Cyclobenzaprine

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