Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery - Trial NCT06271265
Access comprehensive clinical trial information for NCT06271265 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pacira Pharmaceuticals, Inc and is currently Not yet recruiting. The study focuses on Postoperative Pain. Target enrollment is 48 participants.
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Study Focus
Sponsor & Location
Pacira Pharmaceuticals, Inc
Timeline & Enrollment
Phase 1
Feb 01, 2024
Jul 01, 2025
Primary Outcome
The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:,The following model-predicted PK endpoint will be determined:
Summary
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed
 to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for
 postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing
 cardiac surgery, utilizing local infiltration analgesia (LIA).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06271265
Non-Device Trial