PainPhase 1NCT06902103
Pharmacokinetic Study of Single and Multiple Intravenous Administration of Nalbuphine Hydrochloride Injection in Healthy Chinese Volunteers
A Phase 1 study testing Nabufine Hydrochloride Injection in people with Pain, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
Objective：To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects. 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?
- Nabufine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 18 Jan 2024
- 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 aged 18 ~ 65 years (inclusive, calculated from the date of signing the informed consent), half males and half females.
- 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), BMI= weight (kg)/height2(m2).
- Subjects have no plans to donate sperm or eggs, no plans to become pregnant and voluntarily take effective contraceptive measures (including partners) from signing the informed consent form to 3 months after the last dose of investigational product. See Appendix 2 of the protocol for specific contraceptive measures.
- 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.
Who cannot join
- Subjects with any history of clinically significant diseases or conditions that may affect the test results in the opinion of the investigator, including but not limited to the respiratory system (such as obstructive sleep apnea syndrome, chronic bronchial asthma, etc.), cardiovascular system (such as syncope, etc.), digestive system, endocrine system, nervous system (such as epilepsy), urinary system or blood, immune, mental and metabolic disease history.
- Subjects with a history of frequent nausea or vomiting of any etiology.
- Subjects with known history of drug, food or other substance allergy.
- Subjects who have poor peripheral venous access or have a history of needle and blood fainting.
- Pregnant or lactating women, or subjects with positive blood pregnancy test results.
- Subjects with clinically significant abnormal ECG findings at screening, such as QTcF ≥ 450 ms in men, QTcF ≥ 470 ms or PR interval ≥ 200 ms or QRS complex duration ≥ 120 ms in women.
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- Subjects with abnormal vital signs at screening (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; pulse < 50 beats/min or > 100 beats/min) or physical examination, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), chest anteroposterior abnormal subjects with clinical significance (based on the judgment of clinicians).
- 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 at screening.
- Subjects with positive urine drug screening or any history of drug abuse within 1 year prior to screening.
- Subjects who frequently consume alcohol within 6 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 whose alcohol breath test result > 0.0 mg/100 mL, or take any alcohol-containing products within 48 hours before the first use of investigational products, or who cannot stop using any alcohol products during the study.
- Subjects smoke an average of 5 or more cigarettes per day within 3 months prior to screening, or who have used tobacco products within 48 hours before the first use of investigational products, or those who cannot stop using any tobacco products during the study.
- Subjects who have donated blood or experienced massive blood loss (> 400 mL, excluding blood loss during menstruation in women), received blood transfusions or used blood products within 3 months prior to screening.
- Subjects who participated in any clinical trial and administered investigational drugs or investigational medical devices within 3 months prior to screening.
- Subjects who have undergone surgical procedures within 4 weeks prior to screening, or plan to undergo surgical procedures during the study period.
- Subjects who have received attenuated/DNA nucleic acid/recombinant protein vaccination within 4 weeks before screening, or inactivated vaccination within 2 weeks before screening, or plan to receive any vaccination during the study period.
- Subjects who have taken any drugs that inhibit or induce CYP or UGT enzymes within 28 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 the first use of investigational product.
- Subjects who have consumed grapefruit, pomelo, pitaya, mango and other fruits or related products affecting metabolic enzymes within 7 days before the first use of investigational products。
- Subjects who have taken any food or beverage rich in caffeine or xanthine (coffee, tea, cola, chocolate, etc.) within 48 hours before the first use of investigational product, or who do not agree to avoid eating the above food or beverage during the trial.
- Subjects who are not suitable for participating in this clinical trial in the investigator 's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Objective：To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.
- Conditions
- Pain
- Being tested
- Nabufine Hydrochloride Injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nabufine Hydrochloride InjectionDrug
PartA: Nabufine Hydrochloride Injection are administered Intravenous injection single dose
Nabufine Hydrochloride InjectionDrug
PartB: Nabufine Hydrochloride Injection are administered Intravenous injection multi dose
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Nabufine Hydrochloride Injection |
| Group B | Experimental | Not described Receives: Drug: Nabufine Hydrochloride Injection |
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 12 hours after first 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 12 hours after first administration
AUC0-∞ (Total area under the plasma drug concentration-time curve)
Measured: up to 12 hours after first administration
Tmax (Time to achieve Cmax)
Measured: up to 12 hours after first administration
T1/2z (Apparent terminal elimination half-life)
Measured: up to 12 hours after first administration
AUC_%Extrap (The percentage of the portion estimated through extrapolation)
Measured: up to 12 hours after first administration
MRT (Mean residence time)
Measured: up to 12 hours after first administration
CLz (Clearance of the analyte in plasma)
Measured: up to 12 hours after first administration
Occurence of adverse events
Measured: up to 5 days for part A, up to 7 days for part B
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 start20 Dec 2023
- Primary completion26 Dec 2023
- Study completion18 Jan 2024
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902103
- Sponsor's protocol ID
- YZJ-NBF-PK-2302
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Single and Multiple Intravenous Administration of Nalbuphine Hydrochloride Injection in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT06902103
- Acronym / sponsor ID
- YZJ-NBF-PK-2302
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 18 Jan 2024 (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.
Objective：To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Nabufine Hydrochloride Injection |
| Group B | Experimental | Drug: Nabufine Hydrochloride Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged 18 ~ 65 years (inclusive, calculated from the date of signing the informed consent), half males and half females.
- 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), BMI= weight (kg)/height2(m2).
- Subjects have no plans to donate sperm or eggs, no plans to become pregnant and voluntarily take effective contraceptive measures (including partners) from signing the informed consent form to 3 months after the last dose of investigational product. See Appendix 2 of the protocol for specific contraceptive measures.
- 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.
Key exclusion criteria (20 listed)
- Subjects with any history of clinically significant diseases or conditions that may affect the test results in the opinion of the investigator, including but not limited to the respiratory system (such as obstructive sleep apnea syndrome, chronic bronchial asthma, etc.), cardiovascular system (such as syncope, etc.), digestive system, endocrine system, nervous system (such as epilepsy), urinary system or blood, immune, mental and metabolic disease history.
- Subjects with a history of frequent nausea or vomiting of any etiology.
- Subjects with known history of drug, food or other substance allergy.
- Subjects who have poor peripheral venous access or have a history of needle and blood fainting.
- Pregnant or lactating women, or subjects with positive blood pregnancy test results.
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 |
|---|---|---|
| Nabufine Hydrochloride InjectionPartA: Nabufine Hydrochloride Injection are administered Intravenous injection single dose | Drug | Group A |
| Nabufine Hydrochloride InjectionPartB: Nabufine Hydrochloride Injection are administered Intravenous injection multi dose | Drug | Group B |
Primary outcome
Cmax (Maximum drug plasma concentration)
Time frame: up to 12 hours after first 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 12 hours after first administration
AUC0-∞ (Total area under the plasma drug concentration-time curve)
Time frame: up to 12 hours after first administration
Tmax (Time to achieve Cmax)
Time frame: up to 12 hours after first administration
T1/2z (Apparent terminal elimination half-life)
Time frame: up to 12 hours after first administration
AUC_%Extrap (The percentage of the portion estimated through extrapolation)
Time frame: up to 12 hours after first administration
MRT (Mean residence time)
Time frame: up to 12 hours after first administration
CLz (Clearance of the analyte in plasma)
Time frame: up to 12 hours after first administration
Occurence of adverse events
Time frame: up to 5 days for part A, up to 7 days for part B
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 30 Mar 2025.
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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 Nabufine Hydrochloride Injection in people with Pain, run by Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical 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 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 30 Mar 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?
Cmax (Maximum drug plasma concentration) (time frame: up to 12 hours after first administration). The study lists 9 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 30 Mar 2025.