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COMPLETED
NCT07223450
PHASE1

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

Sponsor: Parc de Salut Mar

View on ClinicalTrials.gov

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.

Official title: Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2025-06-12

Completion Date

2025-10-07

Last Updated

2026-05-06

Healthy Volunteers

Yes

Interventions

DRUG

Oxycodone IN

0.1 mg/kg intravenously oxycodone solution administered intranasally

DRUG

oxycodone

oral solution 0.1 mg/kg

Locations (1)

Hospital del Mar Research Institute

Barcelona, Spain