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Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

NCT06481709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-06-12

Study results available
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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.

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Conditions

  • Bioavailability

Interventions

DRUG

RLF-OD032

100 mg/mL oral suspension

DRUG

Kuvan

100 mg powder for oral solution

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

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
2024-07-30
Primary Completion
2024-08-31
Completion
2024-08-31
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 NCT06481709 on ClinicalTrials.gov