At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
RLF-OD032 +1 moredrug
Likely dose
RLF-OD032 100 mgfrom 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.
A Pilot, Phase 1, Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Compare the Pharmacokinetics of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension (Product Code: RLF-OD032) (Test) With Kuvan® (Sapropterin Dihydrochloride) 100 mg Powder for Oral Solution (Reference) and to Evaluate the Effect of Food and the Effect of Water on the Bioavailability of Sapropterin Dihydrochloride 100 mg/mL Oral Suspension in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating RLF-OD032 and Kuvan for Bioavailability. Completed, enrolled 16 participants across 1 site.
Detailed 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. .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioavailability
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedJul 2024
Enrollment StartJul 2024
Primary CompletionAug 2024
TodayJul 2026
First PostedJul 1, 2024
Enrollment StartJul 30, 2024
Primary CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 2.0 years ago
Interventions
RLF-OD032drug
100 mg/mL oral suspension
Kuvandrug
100 mg powder for oral solution