NCT05737576已完成1 期
A Single Center, Randomized, Double-Blind, 2-period, 2-sequence Crossover Designed Study to Evaluate the Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve (AUC0-0.5h)
研究概览
简要总结
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained prior to any trial-related activities；
- •Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent；
- •Body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (BMI) between 18.0 and 26.0 kg/m2 (both ends included)；
- •Are nonsmokers, have not smoked for at least 6 months before entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or not use smokeless tobacco or nicotine products for the duration of the study.
排除标准
- •Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator;
- •have a significant history of the circulatory system, respiratory system, digestive system, urinary system, hematopoietic system, endocrine and metabolic system, neuropsychiatric system, musculoskeletal system, or existing diseases in the above systems may affect the safety of the subjects and interfere with the study data.
- •In the opinion of the investigator, are unsuitable for inclusion in the study.
研究组 & 干预措施
Cohort 1
Experimental
HR011408 injection + NovoRapid®
干预措施: HR011408 injection; NovoRapid® (Drug)
Cohort 2
Experimental
NovoRapid® + HR011408 injection
干预措施: NovoRapid®；HR011408 injection (Drug)
Cohort 3
Experimental
HR011408 injection + NovoRapid®
干预措施: HR011408 injection; NovoRapid® (Drug)
Cohort 4
Experimental
NovoRapid® + HR011408 injection
干预措施: NovoRapid®；HR011408 injection (Drug)
Cohort 5
Experimental
干预措施: HR011408 injection; NovoRapid® (Drug)
Cohort 6
Experimental
干预措施: HR011408 injection; NovoRapid® (Drug)
结局指标
主要结局
Area under the concentration-time curve (AUC0-0.5h)
时间窗: from 0 to 30 minutes after dose administration
Area under the concentration-time curve (AUC)
次要结局
- Area under the concentration-time curve (AUC0-1h)(from 0 to 1 hour after dose administration)
- Area under the concentration-time curve (AUC0-1.5h)(from 0 to 1.5 hours after dose administration)
- Area under the concentration-time curve (AUC0-15min)(from 0 to 15 minutes after dose administration)
- Area under the concentration-time curve (AUC0-2h)(from 0 to 2 hours after dose administration)
- Area under the concentration-time curve (AUC0-10h)(from 0 to 10 hours after dose administration)
- Onset of appearance(from 0 to 8 hours after dose administration)
- Time to 50% maximum observed concentration (time to 50% Cmax)(from 0 to 8 hours after dose administration)
- Time to maximum observed concentration (Tmax)(from 0 to 8 hours after dose administration)
- Maximum observed concentration (Cmax)(from 0 to 8 hours after dose administration)
- Elimination half-life (t1/2)(from 0 to 8 hours after dose administration)
- Incidence and severity of adverse events (AEs)(from Day1 to Day14 after dose administration)
- Area under the concentration-time curve (AUC0-inf)(from 0 to infinity after dose administration)
- Time to 50% maximum observed GIR(time to 50% GIRmax)(from 0 to 10 hours after dose administration)
- Area under the GIR-time curve (AUC)(from 0 to 10 hours after dose administration)
- Time to maximum observed GIR (GIRmax)(from 0 to 10 hours after dose administration)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Comparison of HR011408 and NovoRapid® in Subjects With DiabeticsDiabetesNCT06375031Jiangsu HengRui Medicine Co., Ltd.30
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy SubjectDiabetes in AdultsNCT05147259Jiangsu HengRui Medicine Co., Ltd.62
已完成
1 期
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.Diabetes MellitusNCT00596063Wockhardt25
已完成
2 期
Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus SubjectsType 2 Diabetes Treated With InsulinNCT06473662Roger New153
已完成
1 期
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male SubjectsHealthy VolunteersNCT03776240Prestige Biopharma Limited105