A phase I study to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
A phase I study in healthy males to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
Phosphagenics Limited
44 participants
Aug 3, 2009
Interventional
Conditions
Summary
The purpose of this study is to determine how safe and how well the human body tolerates transdermally delivered oxycodone combined with our patented technology (gel) in different patch forms. We would also like to see how much of the final product reaches the bloodstream after transdermal application.
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 consists of three test groups. 1. A gel mixture containing of 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone; 2. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and; 3. A matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone. Subjects will be randomly assigned to receive only one of the above (or comparator) treatments. Those allocated to the above groups will receive a total of 200mg Oxycodone applied topically to the upper thigh area once for a 72 hour period. The matrix patch is made of a solid film polymer whereas the reservoir patch is made of TPM gel enclosed in a semi-permeable membrane.
Locations(1)
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ACTRN12609000836235