Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01634412 | Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2012 | Jan 1, 2014 | Sep 26, 2014 | 1 | Canada |
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose. A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24, 24-48 and 48-72 hours post-dose.
Every adverse events occurring during the study period will be reported.
| Arm | Type | Description |
|---|---|---|
| SL TNX-102 at pH 3.5 | EXPERIMENTAL | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5 |
| SL TNX-102 at pH 7.1 | EXPERIMENTAL | 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1 |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 5 mg cyclobenzaprine tablet once |
| Cyclobenzaprine IV | ACTIVE_COMPARATOR | 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4 |
| Name | Type | Description |
|---|---|---|
| SL TNX-102 2.4 mg at pH 3.5 | DRUG | 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing |
| SL TNX-102 2.4 mg at pH 7.1 | DRUG | 1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing |
| Cyclobenzaprine Tablet | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
| Cyclobenzaprine IV | DRUG | 1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds |
Inclusion Criteria: Healthy adults * Male or female * Non-smoker * 18-65 years old * BMI \> 18.5 and \< 30.0 * With medically acceptable form of contraception (female only) * With signed informed consent Exclusion Criteria: * Any clinically significant abnormality including ECG abnormalities or v...