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Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla vs. US-sourced Otezla vs. Japan-sourced Otezla) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla vs. US-sourced Otezla) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)

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Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla vs. US-sourced Otezla vs. Japan-sourced Otezla) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla vs. US-sourced Otezla) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Sep 2023

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At a glance

  • Drugs Apremilast (Primary)
  • Indications Ankylosing spondylitis; Atopic dermatitis; Behcet's syndrome; Bullous pemphigoid; COVID 2019 infections; Eczema; Female genital diseases; Hidradenitis suppurativa; Immunological disorders; Juvenile rheumatoid arthritis; Palmoplantar pustulosis; Plaque psoriasis; Psoriasis; Psoriatic arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 31 Aug 2021 Status changed from recruiting to discontinued, due to company decision.
    • 29 Jul 2021 Planned End Date changed from 28 Jul 2021 to 18 Aug 2021.
    • 29 Jul 2021 Planned primary completion date changed from 28 Jul 2021 to 18 Aug 2021.

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