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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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