A single and repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin using a patch.
A two part, open label, phase I single and repeat Investigational Product application study in healthy volunteeers, to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal TPM/O patch.
Phosphagenics Limited
65 participants
Nov 20, 2011
Interventional
Conditions
Summary
The purose of this study is to understand how well Oxycodone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of a patch.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The study has a single (PART 1) and repeat (PART 2) application component. PART 1 will consist of three groups of 15 participants, each receiving a single application of a TPM/O Investigational Product. Participants will be enrolled to receive a single application of one of three dosing regimes (2 type A patches, 3 type A patches or 3 type B patches) that will be applied for 3 days with a subsequent 3 days in-house during which time participants will be monitored while the TPM/O is washed out. Participants will stay in-house for a total of 7 days. Results from PART 1 will be analysed to determine the dose selected for repeat dosing. Participants that undertake the single application part, will not be eligible to participate in the repeat application part. PART 2 will consist of one cohort of 20 participants each receiving repeat applications of the selected TPM/O. Participants will receive 7 applications of TPM/O that will be applied every 3 days for a total of 21 days with a subsequent 6 days in-house during which time participants will be monitored while the TPM/O is washed out. Participants will stay in-house for a total of 28 days. Two patches (patch A and B) will be tested with differing strengthes of oxycodone and excipients. Participants will have either 2 or 3 patches applied by a member of the unit staff to the upper torso area. The patch will remain on the skin for 3 days
Locations(1)
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ACTRN12612000059864