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A Trial of HR18034 in Inguinal Hernia Repair

NCT04551924 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-09-16

No results posted yet for this study

Summary

Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®

Conditions

  • Inguinal Hernia Repair

Interventions

DRUG

HR18034

HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome

DRUG

Naropin

Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weidong Mi, PhD · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-05-30
Completion
2021-05-30

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 NCT04551924 on ClinicalTrials.gov