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Clinical Trial Details

Trial ID: L2732
Source ID: NCT04237129
Associated Drug: Gan & Lee Insulin Aspart
Title: PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Gan & Lee Insulin Aspart
Outcome Measures: Primary: AUCins.0-12h, PK endpoint: The area under the insulin concentration curve from 0 to 12 hours, 0 -12 hours|Cins.max, PK endpoint: The maximum observed insulin concentration, 0 -12 hours|AUCGIR.0-12h, PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours, 0 - 12 hours|GIRmax, PD endpoint: The maximum glucose infusion rate, 0 - 12 hours | Secondary: AUCins.0-2h, PK endpoint: The area under the insulin concentration curve from 0 to 2 hours, 0 - 2 hours|AUCins.0-∞, PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity, 0 - 12 hours|tins.max, PK endpoint: The time to maximum observed insulin concentration, Up to Day 68|t50%-ins(early), PK endpoint: The time to half-maximum insulin concentration before Cins.max, Up to Day 68|t50%-ins(late), PK endpoint: The time to half-maximum insulin concentration after Cins.max, Up to Day 68|t½, PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz, Up to Day 68|λz, PK endpoint: The terminal elimination rate constant of insulin, Up to Day 68|AUCGIR.0-2h, PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours, 0 - 2 hours|tGIR.max, PD endpoint: The time to maximum glucose infusion rate, Up to Day 68|tGIR.50%-early, PD endpoint: The time to half-maximum glucose infusion rate before GIRmax, Up to Day 68|tGIR.50%-late, PD endpoint: The time to half-maximum glucose infusion rate after GIRmax, Up to Day 68|PD endpoint, time to onset of action, Up to Day 68|Safety and local tolerability, Number of participants experiencing treatment-emergent adverse events, Up to Day 68
Sponsor/Collaborators: Sponsor: Gan and Lee Pharmaceuticals, USA
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-08-27
Completion Date: 2019-12-16
Results First Posted:
Last Update Posted: 2020-02-13
Locations: Profil Mainz GmbH & Co. KG, Mainz, Rhineland-Palatinate, D-55116, Germany
URL: https://clinicaltrials.gov/show/NCT04237129