MedTrace Logo

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

NCT07223450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Physiologically Based Pharmacokinetic
  • Healthy Volunteers

Interventions

DRUG

Oxycodone IN

0.1 mg/kg intravenously oxycodone solution administered intranasally

DRUG

oxycodone

oral solution 0.1 mg/kg

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Manchester

    collaborator OTHER

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Rafael De la Torre, PhD · Hospital del Mar Research Institute Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2025-10-07
Completion
2025-10-07

Countries

  • Spain

Study Locations

More Related Trials

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 NCT07223450 on ClinicalTrials.gov