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This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | TNX-102 SL 2.8 mg, under fasting conditions |
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| Treatment B | Experimental | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fasting conditions |
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| Treatment C | Experimental | TNX-102 SL 5.6 mg (2 x 2.8 mg sublingual tablets), under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL | Drug | Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 2.8 mg under fasting conditions | Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose) | Day 1 to Day 6 |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of TNX-102 SL 5.6 mg versus TNX-102 SL 5.6 mg under fed conditions | Blood samples are collected from pre-dose on Day 1 up until Day 6 (144 hours post-dose) | Day 1 to Day 6 |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 2.8 mg versus TNX-102 SL 5.6 mg under fasting conditions | Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose) | Day 1 to Day 15 |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) of TNX-102 SL 5.6 mg under fasted and fed conditions | Blood samples are collected from pre-dose on Day 1 up until Day 15 (360 hours post-dose) | Day 1 to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis Audet, MD | Contract Research Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canada, Quebec | Québec | Quebec | G1P 0A2 | Canada |
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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
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