Clinical trial NCT05737576: The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assigned to HR011408 or NovoRapid®
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the concentration-time curve (AUC0-0.5h)
timeFrame: from 0 to 30 minutes after dose administration
Secondary outcomes:
measure: Area under the concentration-time curve (AUC0-15min)
timeFrame: from 0 to 15 minutes after dose administration
measure: Area under the concentration-time curve (AUC0-1h)
timeFrame: from 0 to 1 hour after dose administration
measure: Area under the concentration-time curve (AUC0-1.5h)
timeFrame: from 0 to 1.5 hours after dose administration
measure: Area under the concentration-time curve (AUC0-2h)
timeFrame: from 0 to 2 hours after dose administration
measure: Area under the concentration-time curve (AUC0-10h)
timeFrame: from 0 to 10 hours after dose administration
measure: Area under the concentration-time curve (AUC0-inf)
timeFrame: from 0 to infinity after dose administration
measure: Onset of appearance
timeFrame: from 0 to 8 hours after dose administration
measure: Time to 50% maximum observed concentration (time to 50% Cmax)
timeFrame: from 0 to 8 hours after dose administration
measure: Time to maximum observed concentration (Tmax)
timeFrame: from 0 to 8 hours after dose administration
measure: Maximum observed concentration (Cmax)
timeFrame: from 0 to 8 hours after dose administration
measure: Elimination half-life (t1/2)
timeFrame: from 0 to 8 hours after dose administration
measure: Area under the GIR-time curve (AUC)
timeFrame: from 0 to 10 hours after dose administration
measure: Time to 50% maximum observed GIR(time to 50% GIRmax)
timeFrame: from 0 to 10 hours after dose administration
measure: Time to maximum observed GIR (GIRmax)
timeFrame: from 0 to 10 hours after dose administration
measure: Incidence and severity of adverse events (AEs)
timeFrame: from Day1 to Day14 after dose administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: