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Human safety studies will be carried out to test whether hop botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the hop supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the hop supplement might affect the metabolism or break down of these probe drugs.
At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the hop dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the hop dietary supplement.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Not yet recruiting
University of Illinois at Chicago
Published on BioPortfolio: 2016-07-29T04:08:21-0400
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A plant genus in the CANNABACEAE family. Best known for the buds of Humulus lupulus L. used in BEER.
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