U.S., May 24 -- ClinicalTrials.gov registry received information related to the study (NCT06987773) titled 'Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions' on May 07.
Brief 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 Start Date: June 30
Study Type: INTERVENTIONAL
Condition:
Bioequivalence
Intervention:
DRUG: RLF-OD032 100 mg/mL oral suspension
Sapropterin dihydrochloride
DRUG: Kuvan 100 MG Powder for Oral Solution
Sapropterin dihydrochloride
Recruitment Status: NOT_YET_...