Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 2:19 PM
Study NCT ID:
NCT07223450
Status:
COMPLETED
Last Update Posted:
2025-10-31
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling
Sponsor:
Parc de Salut Mar
Organization:
Study Overview
Official Title:
Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2025-06
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-dose, 2-period, 2-sequence, fasting, open label, crossover randomized design, comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of intranasal and oral oxycodone solutions. The aim will be to characterize the PK and PD of two formulations of oxycodone (intranasal and oral) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. A total of 8 healthy male/female subjects will be randomly assigned to one of two sequences in the crossover study. All subjects will receive the same dosage of oxycodone intranasal or oral and the sequence will be determined following randomization.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-515461-34-00 | CTIS | None | View |