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

NCT06987773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-28

Study results available
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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.

Conditions

  • Bioequivalence

Interventions

DRUG

RLF-OD032 100 mg/mL oral suspension

Sapropterin dihydrochloride

DRUG

Kuvan 100 MG Powder for Oral Solution

Sapropterin dihydrochloride

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

Principal Investigators

  • Mark L. Freedman, MD,FRCPC · Canada, Ontario - Pharma Medica Research Inc. 4770 Sheppard Ave E

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2025-08-29
Completion
2025-10-28
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987773 on ClinicalTrials.gov