West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT05737576
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
Time frame: from 0 to 30 minutes after dose administration
Area under the concentration-time curve (AUC)
Time frame: from 0 to 15 minutes after dose administration
Time frame: from 0 to 1 hour after dose administration
Time frame: from 0 to 1.5 hours after dose administration
Time frame: from 0 to 2 hours after dose administration
Time frame: from 0 to 10 hours after dose administration
Time frame: from 0 to infinity after dose administration
Time frame: from 0 to 8 hours after dose administration
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Time frame: from 0 to 8 hours after dose administration
Time frame: from 0 to 8 hours after dose administration
Time frame: from 0 to 8 hours after dose administration
Time frame: from 0 to 8 hours after dose administration
Time frame: from 0 to 10 hours after dose administration
Area under the GIR-time curve (AUC0-10h)
Time frame: from 0 to 10 hours after dose administration
Time frame: from 0 to 10 hours after dose administration
Time frame: from Day1 to Day14 after dose administration
Jiangsu HengRui Medicine Co., Ltd.
Industry
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
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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