Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481709
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-06
Brief Title:
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
Sponsor:
APR Applied Pharma Research sa
Organization:
APR Applied Pharma Research sa
Study Overview
Official Title:
A Pilot Phase 1 Randomized Open-Label Single-Dose Four-Way Crossover Study to Compare the Pharmacokinetics of Sapropterin Dihydrochloride 100 mgmL 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 mgmL Oral Suspension in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
In each period subjects will receive a single 10 mgkg dose of sapropterin dihydrochloride on Day 1 under fasting or fed conditions and with or without water followed by 24 hours of PK sampling The study will include a screening visit from Day -30 to Day -1 In each period eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2 There will be a washout period of at least 7 days between doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None