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Clinical trial

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

NCT06987773 is registered in ClinicalTrials.gov with APR Applied Pharma Research s.a. as lead sponsor.

NCT NCT06987773
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
APR Applied Pharma Research s.a.
Phase
Phase 1
Overall status
Completed
Start date
August 20, 2025
Completion date
October 28, 2025
Enrollment
42 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence