drugset / Trial / 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
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 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
Timeline
- Start
- 2013-06
- Primary completion
- 2013-12
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TNX-102-B | Unknown | 2.8 mg | Other |
| Subject | TNX-102-C | Unknown | 2.8 mg | Other |
| Comparator | cyclobenzaprine | Small molecule | 2.8 mg | Other |
| Comparator | cyclobenzaprine | Small molecule | 5 mg | Oral |
Indications
No indication recorded.