A Trial of HR18034 in Inguinal Hernia Repair

• Status: Recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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®

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Ropivacaine

Criteria

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