Skip to content
Pharma Observatory a Scientist.com platform

Clinical trial

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

NCT06481709 is registered in ClinicalTrials.gov with APR Applied Pharma Research s.a. as lead sponsor.

NCT NCT06481709
Email me this page as a PDF

Search trials, sites, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Get the NCT06481709 report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
APR Applied Pharma Research s.a.
Phase
Phase 1
Overall status
Completed
Start date
July 30, 2024
Completion date
August 31, 2024
Enrollment
16 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioavailability