A repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin using different methods of repeat application.
A phase Ib repeat patch application study to determine the pharmacokinetic and safety profiles of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM) using different methods of repeat application in healthy male volunteers.
Phosphagenics Limited
40 participants
Jun 20, 2010
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
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Interventions
The study consists of four test groups. 1. Daily application of a matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone applied to the same site on the upper right or left thigh every day for 14 days. 2. Daily application of a matrix patch system containing 40mg TPM and 200mg Oxycodone, rotating the application between two sites on the upper right or left thigh every day for 14 days. 3. Daily application of a matrix patch system containing 20mg TPM and 100mg Oxycodone applied to the same site on the upper right or left thigh every day for 14 days. 4. Weekly application of a matrix patch system containing 40mg TPM and 200mg Oxycodone to the same site on the upper right or left thigh for 2 weeks.
Locations(1)
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ACTRN12610000514000