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.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
AUC0-∞: Area Under the curve from time zero to infinity
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period
AUC0-t: Area under the concentration-time zero to the last measurable concentration
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period
Cmax: Maximum concentration
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period
Tmax: Time to maximum concentration
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period
t1/2: Half - life
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period
λz: Elimination Rate Constant
Timeframe: Total study duration for a participant is up to 72 days, which includes the screening period