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Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

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Trial Profile

Randomized, Open, 2-way Cross Over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 May 2017

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At a glance

  • Drugs Esomeprazole/naproxen (Primary)
  • Indications Musculoskeletal pain; NSAID-induced gastrointestinal damage; Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Acronyms ESNP
  • Sponsors Hanmi Pharmaceutical

    • Most Recent Events

    • 18 Mar 2014 Primary endpoint 'Peak-drug-concentration' has been met.
    • 18 Mar 2014 Primary endpoint 'Area-under-the-drug-concentration-time-curve' has been met.
    • 18 Mar 2014 Results presented at the 115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.

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