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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

March 31, 2014

Conditions
Healthy Adults
Interventions
DRUG

TNX-102 SL Tablets at 2.8 mg

1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

DRUG

TNX-102-B SL Tablets at 2.8 mg

1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

DRUG

TNX-102-C SL Tablets at 2.8 mg

1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.

DRUG

Cyclobenzaprine tablets

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

Trial Locations (1)

G1P 0A2

PharmaNet, Inc., Québec

All Listed Sponsors
lead

Tonix Pharmaceuticals, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter