At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Oxycodone IN and oxycodone for Physiologically Based Pharmacokinetic and Healthy Volunteers. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.1 mg/kg intravenously oxycodone solution administered intranasally
oral solution 0.1 mg/kg