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A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants

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Trial Profile

A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 May 2026

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At a glance

  • Drugs Omaveloxolone (Primary)
  • Indications Friedreich's ataxia; Malignant melanoma; Mitochondrial disorders; Ocular inflammation; Ocular pain
  • Focus Pharmacokinetics
  • Sponsors Biogen

Most Recent Events

  • 14 May 2026 Status changed from recruiting to completed.
  • 27 Apr 2026 Planned End Date changed from 17 Apr 2026 to 1 May 2026.
  • 27 Apr 2026 Planned primary completion date changed from 17 Apr 2026 to 1 May 2026.

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