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A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans

NCT07279155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-12

No results posted yet for this study

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

DRUG

Bupivacaine Liposome Injection T preparation

Bupivacaine Liposome Injection T preparation

DRUG

Bupivacaine Liposome Injection R preparation

Bupivacaine Liposome Injection R preparation

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2025-07-21
Completion
2025-07-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279155 on ClinicalTrials.gov