NCT06902103已完成1 期

Pharmacokinetic Study of Single and Multiple Intravenous Administration of Nalbuphine Hydrochloride Injection in Healthy Chinese Volunteers

Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2023年12月20日最近更新: 2025年3月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 22
试验地点: 1
主要终点: Cmax (Maximum drug plasma concentration)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objective：To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.
•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.

研究组 & 干预措施

Group A

Experimental

干预措施: Nabufine Hydrochloride Injection (Drug)

Group B

Experimental

干预措施: Nabufine Hydrochloride Injection (Drug)