CompletedPhase 1ACTRN12610000514000

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.


Sponsor

Phosphagenics Limited

Enrollment

40 participants

Start Date

Jun 20, 2010

Study Type

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

Sex: MalesMin Age: 18 YearssMax Age: 49 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates how a pain medication (oxycodone) combined with a vitamin E compound is absorbed through the skin using a patch in healthy men aged 18 to 49. It tests different methods of applying the patch repeatedly to understand how the body processes the drug.

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 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

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)

Australia

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ACTRN12610000514000