The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
PharmaNet, Inc.
Québec, Quebec, Canada
Mean Plasma Concentration (AUC) of Cyclobenzaprine
Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Time frame: 0 to 96 hours
Incidences of Adverse Events
Every adverse events occurring during the study period will be reported.
Time frame: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.