Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions

Phase 1 Completed 42 enrolled APR Applied Pharma Research s.a.

RandomizedCrossoverOpen-labelTreatment

Summary

This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in healthy Participants.

Timeline

Start: 2025-08-20
Primary completion: 2025-08-29
Completion: 2025-10-28

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sapropterin	Unknown	10 mg/kg	—

Indications

No indication recorded.