Trials / Unknown
UnknownNCT04551924
A Trial of HR18034 in Inguinal Hernia Repair
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2021-05-30
- Completion
- 2021-05-30
- First posted
- 2020-09-16
- Last updated
- 2020-09-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04551924. Inclusion in this directory is not an endorsement.