Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

January 31, 2014

Conditions
Healthy Adults
Interventions
DRUG

SL TNX-102 2.4 mg at pH 3.5

1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing

DRUG

SL TNX-102 2.4 mg at pH 7.1

1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing

DRUG

Cyclobenzaprine Tablet

1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water

DRUG

Cyclobenzaprine IV

1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds

Trial Locations (1)

G1P 0A2

PharmaNet, Inc., Québec

All Listed Sponsors
lead

Tonix Pharmaceuticals, Inc.

INDUSTRY

NCT01634412 - Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults | Biotech Hunter | Biotech Hunter