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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Published in: | Pain management (London) 2017-11, Vol.7 (6), p.499-512 |
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Main Authors: | , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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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 |
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ISSN: | 1758-1869 1758-1877 |
DOI: | 10.2217/pmt-2017-0032 |