A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects.

Trial Profile

A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects.

Completed
Phase of Trial: Phase I

Latest Information Update: 12 May 2017

At a glance

  • Drugs YH 4808 (Primary) ; Esomeprazole
  • Indications Gastro-oesophageal reflux; Peptic ulcer
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Yuhan
  • Most Recent Events

    • 12 May 2017 Results (n=123) published in the Alimentary Pharmacology and Therapeutics.
    • 18 Apr 2012 Results presented at the 113th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 30 Mar 2012 Actual patient number changed from 124 to 134 as reported by ClinicalTrials.gov.
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