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

NCT06902090 | Completed Phase 1

• 1 other identifier: YZJ-MLXK-PK-2207
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• 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

  up to 5 days of each treatment period

Study Arms (2)

Group TR

EXPERIMENTAL

Drug: Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.)

Group RT

ACTIVE COMPARATOR

Drug: Meloxicam Nanocrystal Injection (ANJESO®)

Interventions

Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) DRUG

IV, 30 mg

Group TR

Meloxicam Nanocrystal Injection (ANJESO®) DRUG

IV, 30 mg

Group RT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who are able to understand and willing to complete the study in strict compliance with the clinical protocol and sign the informed consent form.
• Male or female subjects aged 18-45 years (inclusive), proper sex ratio.
• Weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 26.0 kg/m2 (inclusive).
• Subjects in good health, no respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic disease history.
• Subjects (including partners) have no donate sperm/eggs from 2 weeks before screening to 3 months after dosing, and voluntarily take appropriate contraceptive measures.

You may not qualify if:

• Subjects who are known to be allergic to meloxicam, drug excipients or other NSAIDs, or have a history of two or more previous drug, food or pollen allergies, or a history of specific allergic diseases (such as asthma, urticaria, eczema, etc.).
• Subjects who have special dietary requirements and cannot accept a unified diet.
• Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting.
• Subjects with clinically significant abnormalities as judged by the investigator based on results of physical examination, vital signs, 12-lead ECG, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function).
• Those who are positive in any index screening of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody, or hepatitis C virus antibody.
• Subjects with previous history (including existing) of gastrointestinal diseases (including gastrointestinal ulcers, gastrointestinal bleeding).
• Subjects who have undergone major trauma surgery or have a history of trauma within 6 months before screening, or plan to undergo surgery during the study period.
• Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening.
• Subjects who frequently consume alcohol within 3 months prior to screening, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits, alcohol or 150 mL of wine), or who cannot stop using any alcohol products during the study, or whose alcohol breath test result \> 0.0 mg/100 mL.
• Subjects who have donated blood or experienced massive blood loss (\> 400 mL), received blood transfusions or used blood products within 3 months prior to screening.
• Subjects who have consumed excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) daily during the 3 months before screening.
• Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or those who cannot stop using any tobacco products during the study.
• Subjects who have participated in any clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study.
• Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study.
• Subjects who have used any drugs that inhibit or induce hepatic metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to screening.

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Pain

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: July 5, 2023
• Primary Completion: July 25, 2023
• Study Completion: August 25, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (1)