NCT06987773

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

A Pivotal, Phase 1, Randomized, Open-Label, Single-Dose, Two-Way Crossover, Bioequivalence Study of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) and Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution in Healthy Participants Under Fed Conditions

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: APR Applied Pharma Research s.a. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

In each period, subjects will receive a single 10 mg/kg dose of sapropterin dihydrochloride on Day 1, under fed conditions, followed by 24 hours of PK sampling. The study will include a screening visit from Day -30 to Day -1. In each period, eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	RLF-OD032 100 mg/mL oral suspension	Sapropterin dihydrochloride
DRUG	Kuvan 100 MG Powder for Oral Solution	Sapropterin dihydrochloride

Timeline

• Start date: 2025-06-30
• Primary completion: 2025-08-30
• Completion: 2025-09-30
• First posted: 2025-05-23
• Last updated: 2025-05-29

Regulatory

• FDA-regulated drug study