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A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases

Trial Profile

A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Dexlansoprazole (Primary)
  • Indications Erosive oesophagitis; Gastro-oesophageal reflux
  • Focus Pharmacokinetics
  • Sponsors Takeda

Most Recent Events

  • 08 Jul 2020 This trial was completed in Poland as per European clinical trial database record (global end of the trial 2020-02-10).
  • 13 Apr 2020 Status changed from suspended to withdrawn prior to enrolment.
  • 03 Oct 2019 Planned End Date changed from 23 Dec 2020 to 23 Dec 2025.

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