CLINICAL RESEARCH POSTER PRESENTATION ABSTRACTS
Please note: All posters will be displayed in
Salons 10-12.
THURSDAY, 10:15-11:00 AM
Zick SM, Al-Rawi S, Normolle D, Djuric Z, Ruffin M.
Phase I single dose pharmacokinetic trial of an encapsulated
ginger standardized to 5%-6-ginerol.
University of Michigan, Michigan Integrative Medicine
szick@umich.edu
PURPOSE: Ginger is a medicinal herb that has
been used to treat colds and flu, digestive disorders including dyspepsia,
colic, nausea, vomiting, gastritis, diarrhea, and as a circulatory stimulant.
This is a study to determine the acute safety profile and the single-dose
pharmacokinetics (including AUC, t1/2, and bioavailability) of a standardized
ginger product in healthy volunteers.
METHODS: This is an open label dose escalation
of ginger in healthy volunteers 18 years and older. The first phase
of the study is a feasibility study in which the middle range of the
dose (1000mg) will be administered to four subjects (two males and two
females) and blood samples will be taken for up to 24 hours for assay
development and validation. The dose escalation phase will include three
participants at each dose levels. Doses will increase from 100mg per
dose to 2000mg per dose. Dose escalation will stop if adverse events
occur that are stage 2 or higher. Blood sample from these participants
will be collected for up to 72 hours.
RESULTS: We will report the results of the single-dose
pharmacokinetics of 6-, 8-, 10 gingerols and shogoals including the
area under the curve (AUC), time of highest concentration in plasma
(t max/C max), half-life (t _), total clearance (CL) for each dose of
ginger from 100 to 2000mg that is detectable in the serum. We will also
report on the occurrence and type of adverse events at all dose levels.
CONCLUSIONS: We will report on how the pharmacokinetic
parameters of a standardized ginger product impact the conclusion of
already conducted RCTs using ginger and the implications for design
of future RCTs using ginger. In addition, we will discuss the next research
steps needed to clarify both long-term/multi-dose pharmacokinetics,
correlation of serum versus tissue ginger levels and chronic adverse
effects for ginger.
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