drugset / Trial / NCT01689259
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
RandomizedParallel-groupOpen-labelTreatment
Summary
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).
Timeline
- Start
- 2012-09
- Primary completion
- 2013-12
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclobenzaprine | Small molecule | 2.4 mg | Other |
| Subject | cyclobenzaprine | Small molecule | 4.8 mg | Other |
| Subject | cyclobenzaprine | Small molecule | 5 mg | Other |
Indications
No indication recorded.