Postoperative Local AnalgesiaPhase 1NCT07279155
A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans
A Phase 1 study testing Bupivacaine Liposome Injection T preparation and Bupivacaine Liposome Injection R preparation in people with Postoperative Local Analgesia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to evaluate the human bioequivalence between the two formulations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Local Analgesia
- What is being tested?
- Bupivacaine Liposome Injection T preparation and Bupivacaine Liposome Injection R preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2025to 21 Jul 2025
- 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
- Healthy male or female between the ages of 18 and 45 years, inclusive;
- 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);
- 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);
- 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.
Who cannot join
- 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;
- 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;
- Abnormalities at the injection site (including skin diseases, open wounds, inflammation, scars, tattoos, etc.), which may affect the drug absorption;
- Subjects who had undergone major trauma surgery within 6 months before the screening, or planned a surgery during the study;
- 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);
- Use of any medication within 14 days prior to dosing (including vitamin products and herbal medicines);
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- 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;
- 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;
- 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;
- 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;
- Subjects who were positive in drug abuse or had a history of drug abuse or use of illegal drugs within the past five years;
- Clinical significance in vital signs, physical examination, ECG and clinical laboratory tests (chemistry, hematology, urinalysis, coagulation function);
- Positive results in any one of Hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody or syphilis serum reagin test;
- Difficulty in venous blood collection or unable to tolerate venipuncture or abdominal subcutaneous injection;
- 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;
- Breath test for alcohol > 0.0 mg /mL;
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to evaluate the human bioequivalence between the two formulations.
- Conditions
- Postoperative Local Analgesia
- Being tested
- Bupivacaine Liposome Injection T preparation, Bupivacaine Liposome Injection R preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome Injection T preparationDrug
Bupivacaine Liposome Injection T preparation
Bupivacaine Liposome Injection R preparationDrug
Also called EXPAREL®
Bupivacaine Liposome Injection R preparation
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine liposome injection T preparation group | Experimental | Not described Receives: Drug: Bupivacaine Liposome Injection T preparation; Drug: Bupivacaine Liposome Injection R preparation |
| Bupivacaine liposome injection R preparation group | Active comparator | Not described Receives: Drug: Bupivacaine Liposome Injection T preparation; Drug: Bupivacaine Liposome Injection R preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax).
Blood samples will be collected.
Measured: From 0 hour predose up to 240 hours postdose.
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t).
Blood samples will be collected.
Measured: From 0 hour predose up to 240 hours postdose.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
Blood samples will be collected.
Measured: From 0 hour predose up to 240 hours postdose.
Secondary outcomes (2)
Observed time to reach Cmax (Tmax).
Blood samples will be collected.
Measured: From 0 hour predose up to 240 hours postdose.
Adverse events (AEs).
Measured: From 0 hour predose up to 35 days postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start9 Jun 2025
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Local AnalgesiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279155
- Sponsor's protocol ID
- HR-BBKY-BE-02
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans
- ClinicalTrials.gov ID
- NCT07279155
- Acronym / sponsor ID
- HR-BBKY-BE-02
- Conditions
- Postoperative Local Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 12 Dec 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.
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to evaluate the human bioequivalence between the two formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine liposome injection T preparation group | Experimental | Drug: Bupivacaine Liposome Injection T preparation, Drug: Bupivacaine Liposome Injection R preparation |
| Bupivacaine liposome injection R preparation group | Active comparator | Drug: Bupivacaine Liposome Injection T preparation, Drug: Bupivacaine Liposome Injection R preparation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the ages of 18 and 45 years, inclusive;
- 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);
- 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);
- 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.
Key exclusion criteria (17 listed)
- 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;
- 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;
- Abnormalities at the injection site (including skin diseases, open wounds, inflammation, scars, tattoos, etc.), which may affect the drug absorption;
- Subjects who had undergone major trauma surgery within 6 months before the screening, or planned a surgery during the study;
- 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);
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 |
|---|---|---|
| Bupivacaine Liposome Injection T preparationBupivacaine Liposome Injection T preparation | Drug | Bupivacaine liposome injection R preparation group, Bupivacaine liposome injection T preparation group |
| Bupivacaine Liposome Injection R preparationAlso: EXPAREL®Bupivacaine Liposome Injection R preparation | Drug | Bupivacaine liposome injection R preparation group, Bupivacaine liposome injection T preparation group |
Primary outcome
Maximum plasma concentration (Cmax).
Time frame: From 0 hour predose up to 240 hours postdose.
Blood samples will be collected.
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t).
Time frame: From 0 hour predose up to 240 hours postdose.
Blood samples will be collected.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
Time frame: From 0 hour predose up to 240 hours postdose.
Blood samples will be collected.
2 secondary outcomes
Observed time to reach Cmax (Tmax).
Time frame: From 0 hour predose up to 240 hours postdose.
Adverse events (AEs).
Time frame: From 0 hour predose up to 35 days postdose.
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 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 Bupivacaine Liposome Injection T preparation and Bupivacaine Liposome Injection R preparation in people with Postoperative Local Analgesia, run by Jiangsu HengRui Medicine 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 4 inclusion and 17 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 12 Dec 2025. 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?
Maximum plasma concentration (Cmax). (time frame: From 0 hour predose up to 240 hours postdose.). The study lists 3 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 12 Dec 2025.