A Trial of HR18034 in Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-05-30

Brief Summary

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

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Detailed Description

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Conditions

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Inguinal Hernia Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

To maintain objectiveness, the study drug will be managed and administered by an independent unblinded team. Subjects, investigators, and all other site staff who directly interact with subjects, evaluate safety and efficacy, and collect subject data, will remain blinded and must not communicate or discuss any study information with the unblinded team.

Study Groups

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dose 1

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

Group Type EXPERIMENTAL

HR18034

Intervention Type DRUG

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

dose 2

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

Group Type EXPERIMENTAL

HR18034

Intervention Type DRUG

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

dose 3

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

Group Type EXPERIMENTAL

HR18034

Intervention Type DRUG

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

dose 4

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

Group Type EXPERIMENTAL

HR18034

Intervention Type DRUG

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

Naropin

Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial

Group Type ACTIVE_COMPARATOR

Naropin

Intervention Type DRUG

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

Interventions

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HR18034

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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subjects will receive HR18034. Naropin, 0.5% Injectable Solution

Eligibility Criteria

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Inclusion Criteria

Able and willing to provide a written informed consent 2、Male or female between 18 and 70 years of age 3、Scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4、Meet the body mass 5、Conform to the ASA Physical Status Classification

Exclusion Criteria

1. Clinically significant abnormal clinical laboratory test value
2. Subjects with poor blood pressure control after medication
3. Subjects with atrioventricular block or cardiac insufficiency
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with a history of ischemic stroke or transient ischemic attack
6. Combination of other pain conditions that may affect postoperative pain assessment
7. Allergic to a drug ingredient or component
8. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
9. History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
10. Subjects with special diets (including tobacco, grapefruit and caffeine)
11. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
12. History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B.
13. Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:
14. Have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically
15. Participated in clinical trials of other drugs (received experimental drugs)
16. History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
17. Pregnant or nursing women
18. No birth control during the specified period of time
19. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No