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drugset / Trial / NCT06481709

Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

NCT06481709 ↗

Phase 1 Completed 16 enrolled APR Applied Pharma Research s.a.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to evaluate the effect of food and the effect of water administration on the bioavailability of sapropterin from the Test product in healthy subjects. .

Timeline

Start
2024-07-30
Primary completion
2024-08-31
Completion
2024-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 10 mg/kg Oral

Indications

No indication recorded.