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A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty

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A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Oct 2020

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At a glance

  • Drugs Bupivacaine (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Pharmacokinetics; Registrational
  • Sponsors Innocoll

    • Most Recent Events

    • 25 Jul 2018 Protocol has been amended to change the phase from 3 to 2.
    • 14 May 2015 Status changed from active, no longer recruiting to completed, per Innocoll AG media release.
    • 01 Apr 2015 Top-line results published in Innocoll media release support a dose selection of 300mg for phase III trials.

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