A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling

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.

NCT Number	NCT07223450
Lead Sponsor	Parc de Salut Mar Collaborators: Food and Drug Administration (FDA), University of Manchester
Conditions	Physiologically Based Pharmacokinetic, Healthy Volunteers
Enrollment	8 participants
Start Date	2025-06-12
Primary Completion	2025-10-07 (estimated)
Study Completion	2025-10-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-06