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A SINGLE-CENTER, SINGLE DOSE THREE DOSE LEVEL STUDY TO INVESTIGATE THE PHARMACOKINETICS AND SAFETY OF BALOXAVIR MARBOXIL IN HEALTHY KOREAN MALE VOLUNTEERS

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A SINGLE-CENTER, SINGLE DOSE THREE DOSE LEVEL STUDY TO INVESTIGATE THE PHARMACOKINETICS AND SAFETY OF BALOXAVIR MARBOXIL IN HEALTHY KOREAN MALE VOLUNTEERS

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 May 2022

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At a glance

  • Drugs Baloxavir-marboxil (Primary)
  • Indications Influenza A virus H5N1 subtype; Influenza A virus infections; Influenza B virus infections; Influenza virus infections
  • Focus Pharmacokinetics
  • Sponsors Roche Korea

    • Most Recent Events

    • 18 May 2022 Results by deriving data from JapicCTI-153090, NCT02954354; NCT02949011, NCT03959332; KCT0003535, developing pharmacokinetics-time to alleviation of symptoms (PK-TTAS) model to study Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B.published in the Clinical Pharmacology and Therapeutics
    • 21 Mar 2020 Results of Non-compartmental analysis estimating PK parameters and tolerability profiles were presented at the 121st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 17 Jun 2019 Status changed from active, no longer recruiting to completed.

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