Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-15; most recent amendment 2026-04-07.
Status change: Not Yet Recruiting → Completed 2026-04-07
Trial Details
NCT Number NCT06987773
Lead Sponsor APR Applied Pharma Research s.a.
Conditions Bioequivalence
Enrollment 42 participants
Start Date 2025-08-20
Primary Completion 2025-08-29 (estimated)
Study Completion 2025-10-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-28