Local view for "https://dbmi-icode-01.dbmi.pitt.edu/dikb/resource/Evidence/381"
| Predicate | Value (sorted: default) |
|---|---|
| rdfs:label |
"evidence_1143"
|
| rdf:type | |
| ?:Evidence_enzyme_system | |
| ?:Evidence_numb_subjects | |
| ?:Evidence_object_dose | |
| ?:Evidence_precip_dose | |
| ?:Evidence_type | |
| ?:Evidence_value | |
| ?:content |
"NOTE: The precip_dose is the dose from days 8-14
route of administration: oral
study duration: 15 days
population:24 healthy volunteers (18 male, 6 female)
tested for known CYP450 polymorphisms?
NO
ages: 19-45
description:
SUBJECTS: Thirty healthy male (22) and female (8) volunteers participated in the study. Informed consent was obtained for all subjects. Mean (range) age, weight, and height for the subjects were 29.6 years (19-45 years), 78.3 kg (46-102 kg), and 179 cm (158-198 cm), respectively.
Twenty-eight of the 30 enrolled subjects completed the study. Two male subjects withdrew their consent, one on Day 8 during a morning clinic visit and the other on Day 12 before the morning dose of venlafaxine. Pharmacokinetic and pharmacodynamic data were evaluated for only 24 subjects. Four subjects were excluded from the analyses because of protocol violations. Two male subjects did not collect complete 96-hour urine samples, and 2 female subjects consumed
xanthene-containing foods or beverages during the study.
METHODS: This was an open-label drug interaction study to evaluate the effects of steady-state venlafaxine on the pharmacokinetic disposition of single oral doses of
risperidone. Single 1 mg doses of risperidone (1 mg Risperdal® tablet, Janssen Pharmaceutica, Titusville, NJ) were administered on Days 1 and 11 with 180 mL of room-temperature water at approximately 10 a.m. following an overnight fast. Multiple doses of venlafaxine (37.5 mg and 75 mg Effexor® tablets, Wyeth-Ayerst Laboratories, Radnor, PA) were administered as follows: 37.5 mg bid from Days 5 through 7 and then 75 mg twice daily from Days 8 through 14. Venlafaxine doses were administered with approximately 240 mL of room- temperature water at 8 a.m. and 8 p.m. with food
(except during the designated fasting period on Day
11). Single-dose pharmacokinetic profiles of risperidone and 9-hydroxyrisperidone and the total active moiety were evaluated on Days 1 through 5 (risperidone alone) and on Days 11 through 15 (risperidone plus venlafaxine).
RESULTS: Risperidone mean oral clearance decreased by 38% (885 +/- 707 mL/min vs. 550 +/- 406 mL/min), and volume of distribution decreased by 17% (215 +/- 91 L vs. 178 +/- 66 L), resulting in a 32% increase in mean AUC_(0–inf) (35.3 +/- 32.1 ng x h/mL vs. 46.7 +/- 31.1 ng x h/mL) and a 29% increase in mean C_max (5.33 +/- 2.15 ng/mL vs. 6.89 +/- 2.96 ng/mL) with venlafaxine coadministration. Both risperidone AUC_(0–inf) and C_max failed to meet bioequivalence criteria (90% CI = 134%-167% and 117%-143%, respectively)."
|
| dc:creator | |
| dc:date |
"09/16/2010 15:08:01"
|
| rdfs:seeAlso |
All properties reside in the graph file:///home/swish/src/ClioPatria/guidelines/dikb.ttl
The resource appears as object in one triple:
{ venlafaxine_increases_auc_risperidone, <http://purl.org/swan/1.2/swan-commons#citesAsSupportingEvidence>, evidence_1143 }