drugset / Trial / NCT03443960
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2018-01-29
- Primary completion
- 2018-04-09
- Completion
- 2018-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclobenzaprine | Small molecule | 5.6 mg | Other |
| Subject | cyclobenzaprine | Small molecule | 30 mg | Other |
Indications
No indication recorded.