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This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules), 30 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (TNX-102 SL) | Experimental | 2 x TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg once daily for 20 consecutive days |
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| Treatment B (AMRIX) | Active Comparator | 1 x AMRIX ER capsule 30 mg once daily for 20 consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL 5.6 mg | Drug | Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them. |
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| Measure | Description | Time Frame |
|---|---|---|
| Steady-State Area Under the Plasma Concentration Versus Time Curve (AUC-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-last dose). | Day 1 to Day 27 |
| Peak Steady-State Plasma Concentration (Cmax-ss) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 27 (168 hours post-dose). | Day 1 to Day 27 |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg versus AMRIX 30 mg | TEAEs will be collected throughout the study and are summarized descriptively by treatment, relationship, and severity for all subjects dosed. | Day 1 to Day 47 |
| Peak Steady-State Plasma Concentration (Cmax-ss) of norcyclobenzaprine from TNX-102 SL 5.6 mg versus AMRIX 30 mg | Blood samples are collected from pre-dose on Day 1 up until Day 47 (648 hours post-last dose). | Day 1 to Day 47 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quebec City | Québec | Quebec | G1P 0A2 | Canada |
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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
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| Amrix 30 mg | Drug | Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it. |
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