Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/851"
| 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 given is the AUC_0-24.
route of administration: oral
study duration: 14 days
population: 12 healthy volunteers (all male), not heavy smokers (<10 cigarettes/day).
tested for known CYP450 polymorphisms?
NO
ages: 18-45
description:
SUBJECTS: Twelve healthy male volunteers aged 18-45 years participated in this study. They were extensively screened within 3 weeks of study entry and had to be medically and mentally healthy, as evidenced by medical history, full physical examination, routine clinical laboratory investigations and electrocardiograms (ECGs). Their body-mass index had to be within the range 19 +/- 29 kg/m2, and they were not allowed to be heavy smokers (less than ten cigarettes or equivalent per day). On admission to the unit, they were screened for alcohol or drug use. No concomitant medication was allowed, with the exception of paracetamol for severe (head)aches.
METHODS: Twelve male subjects meeting the inclusion and exclusion criteria were randomly assigned to one of two groups in this two-period crossover study, with a medication-free washout interval of at least 2 weeks. For each study period, they were admitted to the clinical pharmacology institute 1 day before the start of the study. After admission, subjects were re-screened for alcohol and drugs. During one treatment period, subjects were given cimetidine (800 mg b.i.d. orally) for 14 days, with mirtazapine (30 mg nocte orally) added from the 6th to the 12th day of this period. During the alternate treatment period, cimetidine tablets were replaced by placebo tablets. Medication was taken together with water. Standard meals and snacks were served at fixed times of day. The use of alcohol was forbidden for 48 h prior to the start of the study and up to 48 h after the last study day. There were restrictions with regard to the use of coffee, tea and chocolate. The daily dosages of mirtazapine (30 mg nocte) and cimetidine (800 mg b.i.d.) were in agreement with the manufacturers' recommendations and coincided with current therapeutic practice.
RESULTS: The combined administration of mirtazapine and cimetidine resulted in a statistically significant increase in AUC_0-24 of mirtazapine compared with the administration of mirtazapine as a single drug (AUC_0-24: 979 versus 635 ng x h/ml)."
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| dc:creator | |
| dc:date |
"09/16/2010 12:05:16"
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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:
{ cimetidine_increases_auc_mirtazapine, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1565 }