Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/1092"
| Predicate | Value (sorted: none) |
|---|---|
| rdf:type | |
| rdf:type | |
| rdfs:label |
"evidence_1736"
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| ?:Evidence_type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_value | |
| dc:creator | |
| dc:date |
"09/01/2010 14:29:10"
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| ?:content |
"NOTE: The AUCi/AUC value is calculated from Table 1.
route of administration: oral
study duration: 2 days
population: 10 healthy, nonsmoking volunteers (6 male, 4 female); 7 Caucasian, 2 African-American, 1 Hispanic
tested for known CYP450 polymorphisms? No.
ages: 21-47
description: Ten healthy, nonsmoking volunteers (6 male and 4 female), aged 21–47 years, initiated participation after giving written informed consent. All were active, ambulatory adults, with no evidence of medical disease and taking no other medication. The ethnic distribution was: 7 Caucasian, 2 African-American, 1 Hispanic.
METHODS: The study was a randomized, double blind, 5-way crossover study with at least 7 days elapsing between trials. Medications were: trazodone hydrochloride, 50 mg (Desyrel; Bristol-Myers Squibb, Princeton, NJ); zolpidem tartrate, 5 mg (Ambien; Sanofi-Aventis, Bridgewater, NJ); and clarithromycin, 500 mg (Biaxin; Abbott, North Chicago, IL). The five treatment conditions were: (i) placebo + placebo, (ii) zolpidem + placebo, (iii) zolpidem + clarithromycin, (iv) trazodone + placebo, and (v) trazodone + clarithromycin. All medications were identically packaged in opaque capsules (void space filled with sucrose) and administered orally. Subjects were given 500 mg doses of clarithromycin (or matching placebo) at approximately 24 h, 8 h, and 1 h prior to, and again at 8 h after, administration of zolpidem, trazodone, or placebo.
At 7 am on the study day, subjects were admitted to the Clinical Psychopharmacology Research Unit at Tufts University School of Medicine. They ingested a light breakfast with no caffeine containing beverages or food, and no grapefruit juice. The 500 mg dose of clarithromycin (or matching placebo) was administered with 200 ml of tap water. One hour later, subjects took a “challenge� dose of 5 mg zolpidem, 50 mg of trazodone, or placebo with 200 ml tap water. Volunteers resumed a normal diet at noon (without caffeine).
Venous blood samples were drawn into heparinized tubes prior to challenge dosing and at postdosage times of 1/2, 1, 1 1/2, 2, 2 1/2, 3, 4, 5, 6, and 8 h. Another 500 mg of clarithromycin or placebo was given following the 8-h blood sample. The subjects were then discharged from the study unit. They returned the next morning for a 24-h blood sample. All blood samples were centrifuged, and the plasma was separated and frozen until the time of the assay.
RESULTS: Coadministration of trazodone with clarithromycin compared to placebo significantly increased peak plasma concentration (C_max) (681 ng/ml vs. 922 ng/ml), prolonged t_1/2 (7.1 h vs. 13.9 h), increased AUC (4,668 ng/ml x h vs. 9,275 ng/ml x h), and reduced oral clearance (166 ml/min vs. 89 ml/min)."
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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:
{ clarithromycin_increases_auc_trazodone, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1736 }