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The Granisetron Human Clinical Trial
This study measured the bioavailability of Granisetron, administered via a
small ViaDerm patch (5.6cm2), over a period of 24 hours, and compared it to the
following alternative delivery methods: conventional passive transdermal, oral
(one tablet every 12 hours), and intravenous (IV). The study also evaluated the
tolerability of the ViaDerm system in terms of skin irritation and pain. The
study was conducted on six healthy, adult volunteers in each test group.
The study demonstrated the following advantages of RF-MicroChannel delivery
of Granisetron:
- Granisetron was delivered in therapeutic doses over the entire experiment
period (”active” curve).
- ViaDerm delivery resulted in a concentration increase of up to 12 hours,
and then a constant level of up to 24 hours, relative to peak and valley
profiles for oral and IV, and low plasma levels in the control group.
- MicroChannels remained open and enabled drug delivery for at least 24
hours, after which the patches were removed.
- The test subjects reported no pain during or after the ViaDerm treatment
or while the Granisetron patch was applied on their skin.
- No irritation was detected following the removal of the patch.
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