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A double-blind, randomized, clinical study with a single subcutaneous dose to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of two Regular recombinant human insulins, the test drug being the Regular Human Insulin produced by Bioton SA and the reference medicine Humulin® R produced by Eli Lilly Brasil Ltda using euglycemic and hyperinsulinemic clamp technique in type 1 diabetic research participants (PPES005/17)

Trial Profile

A double-blind, randomized, clinical study with a single subcutaneous dose to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of two Regular recombinant human insulins, the test drug being the Regular Human Insulin produced by Bioton SA and the reference medicine Humulin® R produced by Eli Lilly Brasil Ltda using euglycemic and hyperinsulinemic clamp technique in type 1 diabetic research participants (PPES005/17)

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Oct 2018

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At a glance

  • Drugs Insulin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics

Most Recent Events

  • 20 Jun 2018 New trial record

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