At a glance
ClinicalIndex Comparison Record- ✓Healthy male or female aged 18-65 years, non-smoker
- ✓BMI between 18.5 and 30.0 kg/m²
- ✓Females of childbearing potential must use medically acceptable birth control throughout study
- ✓Capable of providing informed consent
- ✕Any clinically significant abnormality or abnormal laboratory test results at screening
- ✕Positive for hepatitis B, hepatitis C, HIV, drugs of abuse, cotinine, or alcohol at screening
- ✕History of hypersensitivity or allergy to cyclobenzaprine or formulation components
- ✕Use of hepatic enzyme-inducing or inhibiting drugs within 30 days prior to first dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A SINGLE-DOSE, RANDOMIZED, OPEN-LABEL, TWO-WAY CROSSOVER BIOEQUIVALENCE STUDY OF TNX-102 SL (CYCLOBENZAPRINE HCL SUBLINGUAL TABLETS) 2.8 mg FROM TWO MANUFACTURERS IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
In Brief
A Phase 1 clinical trial evaluating Treatment A and Treatment B for Healthy Adults. Completed, enrolled 43 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.