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An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairment Compared to Healthy Adult Volunteers and a Randomized, Open-Label, Single-Dose, Two-Way, Crossover Study to Evaluate the Safety and Pharmacokinetics of HPbetaCD When Administered in DIC075V Compared to Sporanox in Healthy Adult Volunteers.

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Trial Profile

An Open-Label, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of DIC075V in Subjects With Mild or Moderate Chronic Renal Insufficiency and in Subjects With Mild Chronic Hepatic Impairment Compared to Healthy Adult Volunteers and a Randomized, Open-Label, Single-Dose, Two-Way, Crossover Study to Evaluate the Safety and Pharmacokinetics of HPbetaCD When Administered in DIC075V Compared to Sporanox in Healthy Adult Volunteers.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Jan 2013

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At a glance

  • Drugs Diclofenac (Primary) ; Itraconazole
  • Indications Musculoskeletal pain; Osteoarthritis; Rheumatoid arthritis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Javelin Pharmaceuticals

    • Most Recent Events

    • 16 Jun 2009 Results reported in a Javelin Pharmaceuticals media release.
    • 01 May 2009 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 17 Feb 2009 New trial record

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