PainPhase 1NCT06902090
Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects
A Phase 1 study testing Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) and Meloxicam Nanocrystal Injection (ANJESO®) in people with Pain, run by Yangtze River Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) and Meloxicam Nanocrystal Injection (ANJESO®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 25 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration.
- Subjects who have consumed special diets (including grapefruit, chocolate or xanthine-rich foods/beverages) within 48 h before administration.
- Lactating women, or women who test positive for pregnancy.
- Subjects with acute illness from screening period to pre-dose.
- Subjects who should not be included in the investigator 's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.), Meloxicam Nanocrystal Injection (ANJESO®)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.)Drug
IV, 30 mg
Meloxicam Nanocrystal Injection (ANJESO®)Drug
IV, 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Group TR | Experimental | Not described Receives: Drug: Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) |
| Group RT | Active comparator | Not described Receives: Drug: Meloxicam Nanocrystal Injection (ANJESO®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum drug plasma concentration)
Measured: up to 96 hours after drug administration
Tmax (Time to achieve Cmax)
Measured: 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)
Measured: up to 96 hours after drug administration
AUC0-∞ (Total area under the plasma drug concentration-time curve)
Measured: up to 96 hours after drug administration
T1/2z (Apparent terminal elimination half-life)
Measured: up to 96 hours after drug administration
λz (Apparent terminal elimination rate constant)
Measured: up to 96 hours after drug administration
AUC_%Extrap (The percentage of the portion estimated through extrapolation)
Measured: up to 96 hours after drug administration
Vz (Volume of distribution during the terminal phase)
Measured: up to 96 hours after drug administration
CLz (Clearance of the analyte in plasma)
Measured: up to 96 hours after drug administration
Occurence of adverse events
Measured: up to 15 days of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start5 Jul 2023
- Primary completion25 Jul 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902090
- Sponsor's protocol ID
- YZJ-MLXK-PK-2207
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06902090
- Acronym / sponsor ID
- YZJ-MLXK-PK-2207
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TR | Experimental | Drug: Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) |
| Group RT | Active comparator | Drug: Meloxicam Nanocrystal Injection (ANJESO®) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.)IV, 30 mg | Drug | Group TR |
| Meloxicam Nanocrystal Injection (ANJESO®)IV, 30 mg | Drug | Group RT |
Primary outcome
Cmax (Maximum drug plasma concentration)
Time frame: up to 96 hours after drug administration
Tmax (Time to achieve Cmax)
Time frame: 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)
Time frame: up to 96 hours after drug administration
AUC0-∞ (Total area under the plasma drug concentration-time curve)
Time frame: up to 96 hours after drug administration
T1/2z (Apparent terminal elimination half-life)
Time frame: up to 96 hours after drug administration
λz (Apparent terminal elimination rate constant)
Time frame: up to 96 hours after drug administration
AUC_%Extrap (The percentage of the portion estimated through extrapolation)
Time frame: up to 96 hours after drug administration
Vz (Volume of distribution during the terminal phase)
Time frame: up to 96 hours after drug administration
CLz (Clearance of the analyte in plasma)
Time frame: up to 96 hours after drug administration
Occurence of adverse events
Time frame: up to 15 days of each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meloxicam Nanocrystal Injection(Yangtze River Pharmaceutical Group Co., Ltd.) and Meloxicam Nanocrystal Injection (ANJESO®) in people with Pain, run by Yangtze River Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (Maximum drug plasma concentration) (time frame: up to 96 hours after drug administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.