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Bioequivalence Study of Sapropterin Dihydrochloride Oral Suspension (RLF-OD032) and Kuvan in Healthy Participants
NCT06987773Phase 1Completed
- Sponsor
- APR Applied Pharma Research
- Start
- Aug 2025
- Primary completion
- Aug 2025
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of APR-OD032 in phenylketonuria (PKU) (2 arms), sponsored by APR Applied Pharma Research. Primary endpoints: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration, Area Under the Concentration-Time Curve From Time Zero to Infinity and 1 more. Started Aug 2025; status: completed.
02
Drugs
APR-OD032
03
Conditions
phenylketonuria (PKU)
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