Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the Glucose Infusion Rate (GIR) - time curve （Part II）
研究概览
简要总结
This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male subjects aged 18 ~ 45 (including the boundary. value)(Part I). Subjects aged 18 ~ 45 (including the boundary value), male or female(Part II).
- •Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- •Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).
排除标准
- •A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
- •Have a history of hypertension.
- •Severe systemic infectious diseases within 1 month before screening.
- •Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.
- •Presence of any abnormal and clinically significant laboratory tests.
- •12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
- •Known or suspected history of drug abuse or positive urine drug screening test within screening period.
- •Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;
- •Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
研究组 & 干预措施
BIAsp 30
干预措施: Insulin Aspart 30 Injection (Drug)
INS062
干预措施: INS062 injection (Drug)
NovoRapid ®
干预措施: Insulin Aspart (Drug)
HR20014
干预措施: HR20014 injection (Drug)
结局指标
主要结局
Area under the Glucose Infusion Rate (GIR) - time curve （Part II）
时间窗: 0h to 24 hours after dosing
Based on smoothed data
Maximum concentration（Part II）
时间窗: 0 to 120 hours after dosing
Observed value
Area under the Glucose Infusion Rate (GIR) - time curve （Part I）
时间窗: 0 to 10 hours after dosing
Based on smoothed data
Area under the concentration-time curve （Part I）
时间窗: 0 to 10 hours after dosing
Linear Up Log Down
Area under the concentration-time curve （Part II）
时间窗: 0 to 120 hours after dosing
Linear Up Log Down
Maximum concentration（Part I）
时间窗: 0 to 10 hours after dosing
Observed value
Maximum GIR （Part I）
时间窗: 0 to 10 hours after dosing
Based on smoothed data
Maximum GIR（Part II）
时间窗: 0 to 24 hours after dosing
Based on smoothed data
Time to maximum concentration （Part II）
时间窗: 0 to 120 hours after dosing
Observed value
Time to maximum GIR （Part II）
时间窗: 0 to 24 hours after dosing
Based on smoothed data
次要结局
- Terminal half-life （Part I）(0 to 10 hours after dosing)
- Incidence of anti-drug antibody (ADA)（Part I）(from 0 hour after dosing to 3-14 days after the last dose)
- Time to maximum concentration （Part I）(0 to 10 hours after dosing)
- Incidence of anti-drug antibody (ADA)（Part II）(from 0 hour to 7-21 days after the last dose)
- Time to maximum GIR （Part I）(0 to 10 hours after dosing)
- Incidence and severity of adverse events (AEs)（Part I）(from screening to 3-14 days after the last dose)
- Incidence and severity of adverse events (AEs)（Part II）(from screening to 7-21 days after the last dose)