Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects (NCT06902090) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects
China20 participantsStarted 2023-07-05
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax (Maximum drug plasma concentration)
Timeframe: up to 96 hours after drug administration
2
Tmax (Time to achieve Cmax)
Timeframe: up to 96 hours after drug administration
3
AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration)
Timeframe: up to 96 hours after drug administration
4
AUC0-∞ (Total area under the plasma drug concentration-time curve)
Timeframe: up to 96 hours after drug administration
5
T1/2z (Apparent terminal elimination half-life)
Timeframe: up to 96 hours after drug administration
6
λz (Apparent terminal elimination rate constant)
Timeframe: up to 96 hours after drug administration
7
AUC_%Extrap (The percentage of the portion estimated through extrapolation)
Trial details
NCT IDNCT06902090
SponsorYangtze River Pharmaceutical Group Co., Ltd.
. 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.
Timeframe: up to 96 hours after drug administration
8
Vz (Volume of distribution during the terminal phase)
Timeframe: up to 96 hours after drug administration
9
CLz (Clearance of the analyte in plasma)
Timeframe: up to 96 hours after drug administration