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A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

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A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Sep 2022

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At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Diabetes mellitus; Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus First in man; Pharmacokinetics
  • Sponsors Lannett

    • Most Recent Events

    • 13 Sep 2022 Status changed from recruiting to completed.
    • 18 Feb 2022 Planned number of patients changed from 27 to 104.
    • 04 Dec 2019 According to a Lannett media release, the company expect to meet with FDA in the coming months to plan next steps for the clinical advancement of our product, including the design of the biosimilar product development plan and regarding Pivotal Trial Design.

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