Title
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
A Single-Dose, Open-Label, Randomized, Three-Way Crossover Study of the Comparative Bioavailability of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets and of the Effect of Food on the Pharmacokinetics of TNX-102 2.4 mg in Healthy Adults
Phase
Phase 1Lead Sponsor
Tonix PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
cyclobenzaprine ...Study Participants
30The 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.
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.
1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions
Inclusion Criteria: Healthy adults Male or female Non-smoker 18-55 years old BMI > 18.5 and < 30.0 With medically acceptable form of contraception (female only). Exclusion Criteria: Any clinically significant abnormality or vital sign abnormalities Any abnormal laboratory test History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication Positive pregnancy test, breastfeeding or lactating Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors Participation in an investigational study within 30 days prior to dosing Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.
| Event Type | Organ System | Event Term | Treatment A | Treatment B | Treatment C |
|---|
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.
Every adverse events occurring during the study period will be reported.
