Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/905"
| Predicate | Value (sorted: none) |
|---|---|
| rdf:type | |
| rdf:type | |
| rdfs:label | |
| ?:Evidence_type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_value | |
| dc:creator | |
| dc:date |
"09/16/2010 11:13:14"
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| ?:content |
"NOTE: The AUC_i/AUC value given is the AUC_0-inf calculated from Table 1.
route of administration: oral
study duration: 8 days
population: 6 healthy Japanese volunteers (all male); 3 smokers, 3 nonsmokers
tested for known CYP450 polymorphisms?
NO
ages: 26-36
description:
SUBJECTS: Six healthy male Japanese volunteers who had given informed consent participated in this study. Their mean age and body weight were 31 +/- 4 years (range, 26-36 years) and 66.3 +/- 5.1 kg (range, 57-72 kg), respectively. Three subjects were nonsmokers and three were smokers (20-40 cigarettes per day). All subjects were in good health as assessed by medical history, physical examination, routine hematology, blood chemistry, urinary tests, and cardiac function (electrocardiography).
STUDY DESIGN: A randomized crossover design with two phases was used. A 7-day washout period separated the two treatment conditions. Each subject received an oral dose of mexiletine (200 mg) at 7:00 AM with 100 mL of water. In the one phase, they received mexiletine alone (study 1); in the other phase, they received fluvoxamine (50 mg twice a day) for 7 days, and on the eighth day they received mexiletine and fluvoxamine concomitantly at 7:00 AM (study 2). Each subject fasted overnight for at least 10 hours before the administration of mexiletine at 7:00 AM and continued to fast for an additional 6 hours after administration. The subjects were instructed not to take any medications or drink anything that included caffeine or alcoholic beverages for 1 week before the study and throughout the study.
RESULTS: The area under the concentration-time curve and serum peak concentration of mexiletine in study 2 were significantly increased compared with those in study 1 (10.4 +/- 4.85 versus 6.70 +/- 3.21 µg x h/mL, P = .006 and 0.623 +/- 0.133 versus 0.536 +/- 0.164 µg/mL, P = .008, respectively)."
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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:
{ fluvoxamine_increases_auc_mexiletine, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1909 }