A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

• Status: Completed
• Trial end date: 2022-03-22
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. 18 to 65 years old.

2. Scheduled to remove the impacted tooth.

3. Any NRS score ≥5 within 4 hours after the surgery.

4. Willing to comply with the study procedures and requirements.

5. Willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. Subjects who had used other drugs that affect the analgesic effect.

2. Subjects who have infection or other complications on the planned oral surgical site.

3. Subjects with uncontrolled hypertension or hypotension.

4. Subjects with severe cardiovascular and cerebrovascular diseases.

5. Subjects with severe gastrointestinal disease.

6. Subjects with a history of drug or alcohol abuse.

7. Subjects with significant abnormal electrocardiogram.

8. Subjects with significant abnormal laboratory value.

9. Subject who were allergic to the study drug and ingredients.

10. Pregnancy, lactation or having recent pregnant plan.

11. Subjects who participated in other clinical research study 30 days before entering this study.

12. Other conditions unsuitable for participation in the study.