drugset
drugset / Trial / NCT06902090

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

NCT06902090 ↗

Phase 1 Completed 20 enrolled Yangtze River Pharmaceutical Group Co., Ltd.
RandomizedCrossoverSingle-blindBasic science

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.

Timeline

Start
2023-07-05
Primary completion
2023-07-25
Completion
2023-08-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Meloxicam Small molecule 30 mg Intravenous

Indications

No indication recorded.