Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
Condition: Healthy Adults
Intervention: Treatment A; Treatment B
Intervention description: 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.; 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is an open-label, 2-way crossover, single-dose study that is being performed to
      establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers:
      manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial
      drug product. This bioequivalence study will confirm (1) the drug product manufactured from
      these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data
      obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female between 18 and 65 years of age, non-smoker.

          2. Body mass index >18.5 and <30.0 kg/m2

          3. Females of childbearing potential must be willing to use a medically acceptable method
             of birth control throughout the study.

          4. Capable of consent.

        Exclusion Criteria:

          1. Any clinically significant abnormality or abnormal laboratory test results found
             during medical screening

          2. Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or
             alcohol breath test at screening.

          3. History of hypersensitivity to cyclobenzaprine, any of the formulation component, or
             other related drugs.

          4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days
             prior to the first study drug administration.

          5. Positive pregnancy test at screening.

          6. Clinically significant electrocardiogram (ECG) abnormalities or vital sign
             abnormalities at screening.

          7. History of significant alcohol or drug abuse within one year prior to screening

          8. 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.

          9. Use of medication other than topical products without significant systemic absorption
             and hormonal contraceptives

         10. Breast-feeding subject.

         11. Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry,
             orthodontic braces, or surgical manipulations of the tongue.