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Completed

NCT Number: NCT05737576

The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HR011408 injection; NovoRapid®

Drug

HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.

NovoRapid®;HR011408 injection

Drug

NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.

Primary outcomes

  1. Area under the concentration-time curve (AUC0-0.5h)

    Time frame: from 0 to 30 minutes after dose administration

    Area under the concentration-time curve (AUC)

Secondary outcomes

  1. Area under the concentration-time curve (AUC0-15min)

    Time frame: from 0 to 15 minutes after dose administration

  2. Area under the concentration-time curve (AUC0-1h)

    Time frame: from 0 to 1 hour after dose administration

  3. Area under the concentration-time curve (AUC0-1.5h)

    Time frame: from 0 to 1.5 hours after dose administration

  4. Area under the concentration-time curve (AUC0-2h)

    Time frame: from 0 to 2 hours after dose administration

  5. Area under the concentration-time curve (AUC0-10h)

    Time frame: from 0 to 10 hours after dose administration

  6. Area under the concentration-time curve (AUC0-inf)

    Time frame: from 0 to infinity after dose administration

  7. Onset of appearance

    Time frame: from 0 to 8 hours after dose administration

    First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)

  8. Time to 50% maximum observed concentration (time to 50% Cmax)

    Time frame: from 0 to 8 hours after dose administration

  9. Time to maximum observed concentration (Tmax)

    Time frame: from 0 to 8 hours after dose administration

  10. Maximum observed concentration (Cmax)

    Time frame: from 0 to 8 hours after dose administration

  11. Elimination half-life (t1/2)

    Time frame: from 0 to 8 hours after dose administration

  12. Area under the GIR-time curve (AUC)

    Time frame: from 0 to 10 hours after dose administration

    Area under the GIR-time curve (AUC0-10h)

  13. Time to 50% maximum observed GIR(time to 50% GIRmax)

    Time frame: from 0 to 10 hours after dose administration

  14. Time to maximum observed GIR (GIRmax)

    Time frame: from 0 to 10 hours after dose administration

  15. Incidence and severity of adverse events (AEs)

    Time frame: from Day1 to Day14 after dose administration

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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