EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Healthy Volunteers
Interventions
DRUG

SKY0402

Single-injection femoral nerve block. Initial doses of SKY0402 will begin at 0 mg, and 2 mg (high) for the first subject; and 1 mg (low) and 3 mg (high) for the second subject. The next doses will be between 0-80 mg per side, determined prior to randomization of each subsequent subject. The specific subsequent doses will increase, remain the same, or decrease, determined by the P.I. in consultation with the manufacturer of SKY0402. Doses will always remain within the range of 0-80 mg per side, for a total possible dose of 0-160 mg.

Trial Locations (1)

92103

UCSD Medical Center Hillcrest, San Diego

Sponsors
All Listed Sponsors
collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

University of California, San Diego

OTHER