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A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally

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Trial Profile

A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2025

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At a glance

  • Drugs Amoxicillin/clavulanic acid (Primary)
  • Indications Abscess; Aspiration pneumonia; Bacterial infections; Cellulitis; Community-acquired pneumonia; Dental infections; Lymphadenitis; Otitis media; Peritonsillar abscess; Urinary tract infections
  • Focus Pharmacokinetics
  • Sponsors Kaizen Bioscience

Most Recent Events

  • 14 Jul 2025 According to Kaizen Bioscience Co media release, company is preparing to submit a New Drug Application (NDA) in September 2025.
  • 14 Nov 2024 According to Kaizen Bioscience Co media release, company announce plans for its first NDA submission in 1H 2025.
  • 05 Feb 2024 Planned End Date changed from 10 Mar 2023 to 10 Jun 2024.

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