Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
Status:
COMPLETED
Trial end date:
2024-08-31
Target enrollment:
Participant gender:
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.
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