CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
RLF-OD032 100 mg/mL oral suspension +1 moredrug
Likely dose
RLF-OD032 100 mg/mL oral suspensionfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06987773
NCT06987773Phase 1Completed
CompareCT.gov

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

APR Applied Pharma Research s.a.·interventional·Posted May 23, 2025·Updated Apr 28, 2026

In Brief

A Phase 1 clinical trial evaluating RLF-OD032 100 mg/mL oral suspension and Kuvan 100 MG Powder for Oral Solution for Bioequivalence. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
2026
First PostedMay 23, 2025
Enrollment StartAug 20, 2025
Primary CompletionAug 29, 2025
Study CompletionOct 28, 2025
TodayJul 2, 2026
Enrollment to primary: 9 daysPosted 1.1 years ago

Interventions

RLF-OD032 100 mg/mL oral suspensiondrug

Sapropterin dihydrochloride

Kuvan 100 MG Powder for Oral Solutiondrug

Sapropterin dihydrochloride