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Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)

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Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 May 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Axial spondyloarthritis; Crohn's disease; Hidradenitis suppurativa; Juvenile rheumatoid arthritis; Panuveitis; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Spondylitis; Ulcerative colitis; Uveitis
  • Focus Pharmacokinetics; Registrational
  • Acronyms VOLTAIRE-HCLF
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 01 May 2024 According to a Boehringer Ingelheim media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) to treat multiple chronic inflammatory diseases. The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF.
    • 19 Sep 2022 Status changed from active, no longer recruiting to completed.
    • 15 Sep 2022 Planned End Date changed from 30 Aug 2022 to 14 Sep 2022.

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