Who is sponsoring NCT05456490?

NCT05456490 is sponsored by Pacira Pharmaceuticals, Inc.

What drugs are being tested in NCT05456490?

Interventions: Liposomal Bupivacaine 13.3, Bupivacaine, Placebo.

What is the status of NCT05456490?

NCT05456490 is currently COMPLETED.

Last reviewed 2025-03-17 · How we verify

Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers

NCT05456490 PHASE1 COMPLETED

Primary Objective: To assess the safety and tolerability of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers.

Details

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	PHASE1
Status	COMPLETED
Enrolment	54
Start date	Tue Apr 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Healthy

Interventions

Liposomal Bupivacaine 13.3
Bupivacaine
Placebo

Countries

United States