Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/564"
| Predicate | Value (sorted: default) |
|---|---|
| rdfs:label | |
| rdf:type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_type | |
| ?:Evidence_value | |
| ?:content |
"route of administration: oral
study duration: two days
population: 12 healthy volunteers (8 male, 4 female); non-smokers
tested for known CYP450 polymorphisms?
N/A
ages: 20 - 40
description:
Twelve healthy volunteers (8 men and 4 women), aged 20 to 40 years, participated after giving written informed consent. All were active ambulatory non-smoking 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.
The study had a double-blind, randomized, 5-way
crossover design, with at least 7 days elapsing between
treatments. Medications were separately and identically
packaged in opaque capsules and administered orally. 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.
Coadministration of zolpidem with ketoconazole (treatment C) significantly prolonged zolpidem elimination half-life, increased total AUC, and decreased apparent oral clearance when compared to zolpidem plus placebo (treatment B; Figure 3 and Table II). Zolpidem AUC during treatment C was increased by a factor of 1.83 + 0.24 (mean +/- SE) compared to treatment B values, and clearance during treatment C was reduced to 64% +/- 7% of treatment B values."
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| dc:creator | |
| dc:date |
"08/10/2010 14:42:58"
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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:
{ ketoconazole_increases_auc_zolpidem, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1708 }