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

Suspended
Phase of Trial: Phase I

Latest Information Update: 19 Sep 2017

At a glance

  • Drugs Dexlansoprazole (Primary)
  • Indications Gastro-oesophageal reflux
  • Focus Pharmacokinetics
  • Sponsors Takeda
  • Most Recent Events

    • 14 Sep 2017 Planned End Date changed from 1 Jul 2017 to 23 Dec 2020.
    • 14 Sep 2017 Planned primary completion date changed from 1 Jul 2017 to 23 Dec 2020.
    • 07 Mar 2016 Status changed from recruiting to suspended as reported by ClinicalTrials.gov record.
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