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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TR | Experimental |
| |
| Group RT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) | Drug | IV, 30 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum drug plasma concentration) | up to 96 hours after drug administration | |
| Tmax (Time to achieve Cmax) | up to 96 hours after drug administration | |
| AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration) | up to 96 hours after drug administration | |
| AUC0-∞ (Total area under the plasma drug concentration-time curve) | up to 96 hours after drug administration | |
| T1/2z (Apparent terminal elimination half-life) | up to 96 hours after drug administration | |
| λz (Apparent terminal elimination rate constant) | up to 96 hours after drug administration | |
| AUC_%Extrap (The percentage of the portion estimated through extrapolation) | up to 96 hours after drug administration | |
| Vz (Volume of distribution during the terminal phase) | up to 96 hours after drug administration | |
| CLz (Clearance of the analyte in plasma) | up to 96 hours after drug administration | |
| Occurence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
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| Meloxicam Nanocrystal Injection (ANJESO®) |
| Drug |
IV, 30 mg |
|
| up to 15 days of each treatment period |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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