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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01889173 | Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2013 | Mar 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, and 48 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 and 24-48 hours post-dose.
Every adverse events occurring during the study period will be reported.
| Arm | Type | Description |
|---|---|---|
| TNX-102 SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg |
| TNX-102-B SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg |
| TNX-102-C SL Tablets at 2.8 mg | EXPERIMENTAL | 1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg |
| Cyclobenzaprine tablets | ACTIVE_COMPARATOR | 1 x 5 mg cyclobenzaprine oral tablet |
| Name | Type | Description |
|---|---|---|
| TNX-102 SL Tablets at 2.8 mg | DRUG | 1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-B SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| TNX-102-C SL Tablets at 2.8 mg | DRUG | 1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it. |
| Cyclobenzaprine tablets | DRUG | 1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water |
Inclusion Criteria: * Healthy adults * Male or female * 18-65 years old * Non-smoker * 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...