Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/856"
| 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 |
"NOTE: The AUC_i/AUC value is the AUC_0-inf of the oral dose of duloxetine. The object drug's dose given is the oral dose.
route of administration: oral (both duloxetine and fluvoxamine), and IV (duloxetine)
study duration: 24 days
population: 14 healthy smokers (all male)
tested for known CYP450 polymorphisms? No
ages: 18-65
description: Healthy subjects were selected by the investigators based on their medical history, physical examination, ECGs and routine clinical laboratory test results. Up to 18 male smokers (aged 18–65 years) were to be enrolled in the fluvoxamine study. Sixteen men who were smokers were enrolled, and 14 completed the study. Two subjects were withdrawn by the investigator before receiving the study drug. The mean (+/- SD) age of the subjects was 37 +/- 11 years, the mean height was 174 +/- 6 cm, the mean bodyweight was 76.9 +/- 10.6 kg and the mean body mass index (BMI) was 25.4 +/- 2.9 kg/m2. The majority of subjects were Caucasian (81%) and the rest were African American.
METHODS: This was an open-label, four-period, sequential crossover study. The dosing sequence started with duloxetine administration only (intravenous or oral; dosing periods 1 and 2), followed by duloxetine (intravenous or oral) in the presence of steady-state fluvoxamine (dosing periods 3 and 4). Duloxetine administration was planned on days 1, 5, 14 and 20 and fluvoxamine was administered from days 8 to 24. The sequence of intravenous and oral duloxetine dosing was randomized. The oral dose of duloxetine was a single 60-mg dose and the intravenous dose of duloxetine was a 10-mg infusion over 30 minutes. Fluvoxamine was initiated at a single dose of 50 mg for 1 day followed by 100 mg once daily for at least 16 additional days. Subjects unable to tolerate fluvoxamine 100 mg once daily were discontinued from the study. The washout period between each dose of duloxetine was a minimum of 4 days and a maximum of 14 days.
RESULTS: The oral duloxetine C_max and AUC_inf were increased by 141% (90% CI 93, 200) and 460% (90% CI 359, 584), respectively, whereas the intravenous duloxetine AUC_inf increased by 170% (90% CI 121, 230)."
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| dc:creator | |
| dc:date |
"09/01/2010 15:15:26"
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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_duloxetine, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1265 }