NCT07279155

A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to evaluate the human bioequivalence between the two formulations.

Conditions

• Postoperative Local Analgesia

Interventions

Type	Name	Description
DRUG	Bupivacaine Liposome Injection T preparation	Bupivacaine Liposome Injection T preparation
DRUG	Bupivacaine Liposome Injection R preparation	Bupivacaine Liposome Injection R preparation

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-07-21
• Completion: 2025-07-21
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: China