Phase 1
N=43
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
Healthy Adults
Bottom Line
View on ClinicalTrials.gov: NCT03168022 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Mean Plasma Concentration (AUC) of Cyclobenzaprine — 70066.90; 64711.53 pg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Treatment A (Drug); Treatment B (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Concentration (AUC) of Cyclobenzaprine |
70066.90; 64711.53 | — |
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions. |
18; 19 | — |
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
- Healthy male or female between 18 and 65 years of age, non-smoker.
- Body mass index >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 hypersensitivity 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
- Breast-feeding subject.
- Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue.
Data sourced from ClinicalTrials.gov (NCT03168022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.