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Generic pain injection put to the test against Brand-Name drug
NCT ID NCT06902090
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests a generic version of meloxicam nanocrystal injection (a pain reliever) against the brand-name drug ANJESO® in 20 healthy adults aged 18 to 45. Researchers compare how the body absorbs and processes each drug, and check for side effects. The goal is to see if the generic version is safe and behaves similarly to the original.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- meloxicam nanocrystal injection
- What this could lead to
- If successful, this could show that the generic version works similarly to the brand-name drug, potentially offering a more affordable pain treatment option.
- What could go wrong
- This is an early-phase study with only 20 healthy people, so it cannot prove the drug works for pain. Side effects are possible, and results may not apply to patients with pain conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Aug 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Male or female subjects aged 18-45 years (inclusive), proper sex ratio. 3. 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). 4. 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. 5. 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: 1. 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.). 2. Subjects who have special dietary requirements and cannot accept a unified diet. 3. Subjects who have poor peripheral venous access or cannot tolerate venous puncture or have a history of needle and blood fainting. 4. 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). 5. 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. 6. Subjects with previous history (including existing) of gastrointestinal diseases (including gastrointestinal ulcers, gastrointestinal bleeding). 7. 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. 8. Subjects with a history of drug abuse, drug use within 6 months before screening, or positive drug abuse screening. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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. 14. Subjects who have received vaccination within 30 days prior to screening, or plan to receive vaccination during the study. 15. 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. 16. Subjects who have taken any prescription drugs, over-the-counter drugs, health products, vitamins, and Chinese herbal medicines within 14 days before administration. 17. Subjects who have consumed special diets (including grapefruit, chocolate or xanthine-rich foods/beverages) within 48 h before administration. 18. Lactating women, or women who test positive for pregnancy. 19. Subjects with acute illness from screening period to pre-dose. 20. Subjects who should not be included in the investigator 's opinion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
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