A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling
Status:
COMPLETED
Trial end date:
2025-10-07
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Parc de Salut Mar
Collaborators:
Food and Drug Administration (FDA) University of Manchester