Diabetes
Conditions
Brief summary
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
Interventions
DRUGHR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
DRUGNovoRapid®；HR011408 injection
NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Crossover Assigned to HR011408 or NovoRapid®
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Informed consent obtained prior to any trial-related activities； 2. Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent； 3. 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)； 4. 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.
Exclusion criteria
1. Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator; 2. 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. 3. In the opinion of the investigator, are unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve (AUC0-0.5h) | from 0 to 30 minutes after dose administration | Area under the concentration-time curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (AUC0-2h) | from 0 to 2 hours after dose administration | — |
| Area under the concentration-time curve (AUC0-10h) | from 0 to 10 hours after dose administration | — |
| Area under the concentration-time curve (AUC0-inf) | from 0 to infinity after dose administration | — |
| Onset of appearance | from 0 to 8 hours after dose administration | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) |
| Time to 50% maximum observed concentration (time to 50% Cmax) | from 0 to 8 hours after dose administration | — |
| Area under the concentration-time curve (AUC0-15min) | from 0 to 15 minutes 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 | — |
| Area under the GIR-time curve (AUC) | from 0 to 10 hours after dose administration | Area under the GIR-time curve (AUC0-10h) |
| Time to 50% maximum observed GIR(time to 50% GIRmax) | from 0 to 10 hours after dose administration | — |
| Time to maximum observed GIR (GIRmax) | from 0 to 10 hours after dose administration | — |
| Incidence and severity of adverse events (AEs) | from Day1 to Day14 after dose administration | — |
| Time to maximum observed concentration (Tmax) | from 0 to 8 hours after dose administration | — |
Countries
China
Outcome results
None listed