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A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R

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Trial Profile

A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Apr 2022

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At a glance

  • Drugs Insulin (Primary)
  • Indications Diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms RHINE-1
  • Sponsors Biocon

    • Most Recent Events

    • 01 Apr 2022 Primary endpoint maximum glucose infusion rate (GIRmax) has been met, according to results published in the Diabetes, Obesity and Metabolism.
    • 01 Apr 2022 Primary endpoint of Maximum observed insulin concentration (Cins.max) has been met, according to results published in the Diabetes, Obesity and Metabolism.
    • 01 Apr 2022 Primary endpoint Area under the glucose infusion rate curve(AUCGIR).0-12h has been met, according to results published in the Diabetes, Obesity and Metabolism.

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