Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/1497"
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?:Evidence_type | |
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dc:creator | |
dc:date |
"09/22/2010 13:58:46"
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?:content |
"NOTE: The AUC_i/AUC value is calculated from Table II and is not statistically significant
route of administration: oral
study duration: 2 days
population: 11 healthy volunteers, all nonsmokers
tested for known CYP450 polymorphisms?
NO
ages: 20-40
description:
SUBJECTS: Twelve healthy volunteers (8 men and 4 women), aged 20 to 40 years, participated after giving written informed consent. All were active ambulatory nonsmoking adults, with no evidence of medical disease and taking no other medications. Female subjects were not taking oral contraceptives and did not have contraceptive implants. One of the subjects did not ingest zolpidem as instructed during treatment; accordingly mean values for itraconazole treatment, n=11.
METHODS: At 8 AM on study day 1, subjects entered the outpatient Clinical Psychopharmacology Research Unit where they received the initial dose of azole (or placebo) and remained under observation for 30 minutes. Subjects took a second dose of azole (or placebo) at home at 4 PM on day 1. On the morning of day 2, after ingesting a standardized light breakfast with no caffeine-containing food or beverages and no grapefruit juice, they returned to the Research Unit at approximately 7:30 AM. They fasted until 12 noon, after which they resumed a normal diet (without grapefruit juice or caffeine-containing food or beverages). The third dose of azole (or placebo) was given at 8 AM, and the single dose of zolpidem or placebo was given at 9 AM. A final azole (or placebo) dose was given at 5 PM.
RESULTS: Coadministration of zolpidem with itraconazole reduced clearance (320 and 338 mL/min), but differences compared to the zolpidem plus placebo treatment did not reach significance.
See Table II."
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rdfs:seeAlso |
All properties reside in the graph file:///home/swish/src/ClioPatria/guidelines/dikb.ttl
The resource appears as object in one triple:
{ itraconazole_increases_auc_zolpidem, <http://purl.org/swan/1.2/swan-commons#citesAsRefutingEvidence>, evidence_1138 }