A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects

Conditions

• Healthy Subjects (HS)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• TNX-102 SL — DRUG
  Cyclobenzaprine HCl sublingual tablets. The tablets are yellow, round, and biconvex with a "T" debossed on one face

Study Details

Primary Objectives: To characterize the pharmacokinetic (PK) profile and dose proportionality of cyclobenzaprine and norcyclobenzaprine following administration of 2.8 mg and 5.6 mg of TNX-102 SL (either one or two 2.8 mg tablets) under fasting conditions in Japanese and Chinese subjects. To retrospectively compare PK data from the Japanese and Chinese study subjects with existing data from a non-Asian Phase 1 study investigating the administration of 2.8 mg and 5.6 mg of TNX-102 SL under fasting conditions. Secondary Objective: To assess the safety and tolerability of TNX-102 SL (2.8 mg and 5.6 mg) in healthy Japanese and Chinese subjects.

Key Dates

Start date

Mar 18, 2022

Status verified

Mar 2026

Primary completion

Apr 30, 2022

Completion

Apr 30, 2022

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: A single 2.8 mg dose of TNX-102 SL, administered as one 2.8 mg sublingual tablet
• Experimental: A single 5.6 mg dose of TNX-102 SL, administered as two 2.8 mg sublingual tablets

Primary Outcome Measure

AUC0-∞: Area Under the curve from time zero to infinity [ Time Frame: Total study duration for a participant is up to 72 days, which includes the screening period ]

Locations (1)

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