Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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).