Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 1 x TNX-102 2.4 mg gelcap under fasting conditions arm 2: 1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions arm 3: 1 x TNX-102 2.4 mg gelcap under fed conditions

Interventions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C
Intervention descriptions: intervention 1: TNX-102 2.4 mg - 1 gelcap once under fasting conditions. intervention 2: Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions intervention 3: TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Protocol document: