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A Dose Block-randomized, Double-blind, Placebo- and Active-controlled, Single and Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

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Trial Profile

A Dose Block-randomized, Double-blind, Placebo- and Active-controlled, Single and Multiple Dosing, Dose-escalation Clinical Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Fexuprazan (Primary) ; Esomeprazole
  • Indications Gastro-oesophageal reflux
  • Focus Adverse reactions
  • Sponsors Daewoong Pharmaceutical

    • Most Recent Events

    • 16 Mar 2019 Results (n=100) assessing the effects of CYP2C19 genotype on pharmacokinetics and pharmacodynamics of DWP14012 using blood samples obtained from the subjects who participated in this study, were presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 04 Jun 2018 Results evaluating safety, tolerability, pharmacodynamics and pharmacokinetics published in the Alimentary Pharmacology and Therapeutics
    • 24 Mar 2018 Results assessing endogenous metabolic markers for cyp3a and gastric PH to explain pharmacokinetic non linearity of dwp14012, were presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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