The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
The purpose of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects, based on the pharmacokinetic parameter (PK) AUC (INS-LIS 0-8h) and the pharmacodynamic parameter (PD) AUC (GIR 0-8h) and also assess the safety and local tolerability of the two insulin preparations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Dosage form- Subcutaneous Injection
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)
Glucose clamp will be terminated 10 hours post dose and the primary pharmacokinetic bioequivalance will be calculated based on the Area under the curve (AUC) between 0 - 8 hours postdose of the study medication.
Time frame: 8 hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-8h)
Glucose clamp will be terminated 10 hours post dose and the primary pharmacodymanic bioequivalance will be calculated based on the Area under the curve (AUC) for the glucose infusion rate (GIR) between 0 - 8 hours postdose of the study medication
Time frame: 8 hrs post dose
Pharmacokinetic parameters:Maximum concentration (Cmax)
Time frame: over 10 hrs post dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs
AUC (GIR 0-4h), AUC (GIR 4-8h), AUC (GIR 4-10h), AUC (GIR 0-10h)
Time frame: over 10 hrs post dose
Safety endpoints
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Time frame: over 10 hrs post dose
Pharmacokinetic parameter: Area under curve from 0-10hrs
AUC (INS-LIS 0-4 h), AUC (INS-LIS 4-8 h), AUC (INS-LIS 4-10h), AUC (INS-LIS 0-10 h)
Time frame: over 10 hours postdose
Pharmacokinetic Parameters: tmax and t1/2
Time frame: Over 10 hours postdose
Pharmacodynamic parameter: GIR max and tGIR max
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: over 10 hrs postdose