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A Pilot, Phase 1, Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Compare the Pharmacokinetics of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) (Test) With Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution (Reference) and to Evaluate the Effect of Food and the Effect of Water on the Bioavailability of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension in Healthy Subjects

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Trial Profile

A Pilot, Phase 1, Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Compare the Pharmacokinetics of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) (Test) With Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution (Reference) and to Evaluate the Effect of Food and the Effect of Water on the Bioavailability of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jun 2025

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At a glance

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

Most Recent Events

  • 12 Dec 2024 Status changed from active, no longer recruiting to completed.
  • 18 Sep 2024 According to a Relief Therapeutics media release, the Company expects topline results in October 2024 and these results will inform further development of RLF-OD032 toward a pivotal trial and potential regulatory submission under the 505(b)(2) NDA pathway in the United States.
  • 18 Sep 2024 According to a Relief Therapeutics media release, Status changed from recruiting to active, no longer recruiting.

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