NCT06902090

Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Yangtze River Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary Objective：To compare the pharmacokinetic profiles between meloxicam nanocrystal injection (strength: 1 mL: 30 mg, Yangtze River Pharmaceutical Group Co., Ltd.) and the originator meloxicam nanocrystal injection (trade name: ANJESO®, strength: 1 mL: 30 mg, Baudax Bio Inc.) in healthy volunteers. Secondary Objective：To observe the safety and tolerability of meloxicam nanocrystal injection and ANJESO® in healthy volunteers.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.)	IV, 30 mg
DRUG	Meloxicam Nanocrystal Injection (ANJESO®)	IV, 30 mg

Timeline

• Start date: 2023-07-05
• Primary completion: 2023-07-25
• Completion: 2023-08-25
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: China