A Phase I study of the pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxymorphone transdermal patch system

Characterize the pharmacokinetic profile and tolerability of two tocopheryl phosphate mixture/oxymorphone patch formulations in healthy subjects, and the active metabolite (6-OH-oxymorphone). Fifteen participants received a single application of oxymorphone patches +/− capsaicin for 72 h and were cr...

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Bibliographic Details
Published in:Pain management (London) 2017-11, Vol.7 (6), p.499-512
Main Authors: Gavin, Paul D, Simon, Lee S, Schlagheck, Thomas, Smith, Alisha J, Krishnarajah, Janakan
Format: Article
Language:English
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Summary:Characterize the pharmacokinetic profile and tolerability of two tocopheryl phosphate mixture/oxymorphone patch formulations in healthy subjects, and the active metabolite (6-OH-oxymorphone). Fifteen participants received a single application of oxymorphone patches +/− capsaicin for 72 h and were crossed-over for another 72 h. Plasma oxymorphone was detected approximately 7 h and 6-OH-oxymorphone after approximately 18-19 h postapplication of both formulations, respectively. For oxymorphone, median t was 24 h, and C /C ratio was approximately 2.4. The most frequently reported treatment-related adverse event was application site reaction, mainly with capsaicin formulation. Tocopheryl phosphate mixture/oxymorphone transdermal patches can successfully deliver therapeutic amounts of oxymorphone in a sustained manner over 72 h and are well tolerated. ANZCTR registration number: ACTRN12614000613606
ISSN:1758-1869
1758-1877
DOI:10.2217/pmt-2017-0032