A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Trial Profile

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Dec 2012

At a glance

  • Drugs Esomeprazole (Primary)
  • Indications Gastro-oesophageal reflux; Helicobacter infections; Peptic ulcer; Reflux oesophagitis
  • Focus Pharmacokinetics
  • Most Recent Events

    • 11 Dec 2012 Actual end date changed from Jul 2012 to Jun 2012 as reported by ClinicalTrials.gov.
    • 01 Jul 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 17 May 2012 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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