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A Pivotal, Phase 1, Randomized, Open-Label, Single-Dose, Two-Way Crossover, Bioequivalence Study of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) and Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution in Healthy Participants Under Fed Conditions

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Trial Profile

A Pivotal, Phase 1, Randomized, Open-Label, Single-Dose, Two-Way Crossover, Bioequivalence Study of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) and Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution in Healthy Participants Under Fed Conditions

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 31 May 2025

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At a glance

  • Drugs Sapropterin (Primary) ; Sapropterin
  • Indications Phenylketonuria
  • Focus Pharmacokinetics; Registrational
  • Sponsors APR Applied Pharma Research

Most Recent Events

  • 29 May 2025 New trial record

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