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Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(G), US-Lantus, and EU-Lantus

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Trial Profile

Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(G), US-Lantus, and EU-Lantus

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jul 2025

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At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Xentria

Most Recent Events

  • 16 Jul 2025 Status changed from recruiting to completed.
  • 05 Nov 2024 Planned End Date changed from 1 Aug 2025 to 1 Jul 2025.
  • 05 Nov 2024 Planned primary completion date changed from 1 Jul 2025 to 1 Jun 2025.

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