Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults
Status:
Completed
Trial end date:
2014-01-01
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
sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in
increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1
and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and
cyclobenzaprine (5 mg tablets, or 2.4 mg iv).