New painkiller put to the test in healthy volunteers
NCT ID NCT07279155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checked whether a new form of the painkiller bupivacaine (liposomal) is absorbed in the body the same way as the approved version. It involved 36 healthy adults aged 18-45. The goal was to measure drug levels in the blood, not to treat pain directly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jul 2025
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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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. Healthy male or female between the ages of 18 and 45 years, inclusive; 2. At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2); 3. Subjects (including male subjects) agree to adopt effective physical contraceptive measurements and not plan pregnancy, or sperm/ovum donation during the study till 90 days after the last administration. Pregnancy tests of female subjects must be negative before and during the study and female subjects were not lactating. (see Section 14.2 for details); 4. Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent. Exclusion Criteria: 1. Subjects with specific allergic diseases (asthma, urticaria, eczema, etc.) or allergic constitution (such as allergy to two or more drugs, food or pollen), or allergy to excipients and bupivacaine; 2. Subjects with history of serious diseases including but not limited to circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders; 3. Abnormalities at the injection site (including skin diseases, open wounds, inflammation, scars, tattoos, etc.), which may affect the drug absorption; 4. Subjects who had undergone major trauma surgery within 6 months before the screening, or planned a surgery during the study; 5. Using any drugs that inhibit or induce the metabolism of drugs in liver within 30 days before the study (such as: inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones and antihistamines); 6. Use of any medication within 14 days prior to dosing (including vitamin products and herbal medicines); 7. Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 3 months before the trial, or plan to participate in other clinical trials during the study; 8. Blood donation or massive loss (≥ 200 ml, excluding blood loss during menstrual period), received blood transfusion or blood products within 3 months before the trial; 9. Subjects who take more than 5 cigarettes per day on average within 3 months prior to the study or do not agree to prohibit smoking during the study; 10. Drinking frequently within 6 months before the trial, meaning 14 units of alcohol per week(1 unit = 360 mL beer or 45 mL of 40% spirits, or 150 mL wine), or disagree with the prohibition of alcohol during the study; 11. Subjects who were positive in drug abuse or had a history of drug abuse or use of illegal drugs within the past five years; 12. Clinical significance in vital signs, physical examination, ECG and clinical laboratory tests (chemistry, hematology, urinalysis, coagulation function); 13. Positive results in any one of Hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody or syphilis serum reagin test; 14. Difficulty in venous blood collection or unable to tolerate venipuncture or abdominal subcutaneous injection; 15. Consumption of any special diet within 48 hours prior to dosing (including grapefruit, chocolate, xanthine rich food / beverage) and / or excessive consumption of tea, coffee, grapefruit juice, caffeinated beverage (more than 8 cups per day, 200 mL per cup) for the past three months; 16. Breath test for alcohol \> 0.0 mg /mL; 17. Unable to complete the study due to personal reasons or other factors considered by the investigator as unsuitable to participate in the study (such as inability to understand the study requirements, poor compliance, etc.).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jilin University First Hospital
Changchun, Jilin, 130000, China