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Titolo:
Multiple-dose tolerability, pharmacodynamics, and pharmacokinetics of the quinolizinone hypnotic Ro 41-3696 in elderly subjects
Autore:
Dingemanse, J; Pedrazzetti, E; van Giersbergen, PLM;
Indirizzi:
Jacor Res, Bottmingen, Switzerland Jacor Res Bottmingen SwitzerlandJacor Res, Bottmingen, Switzerland F Hoffmann La Roche & Co Ltd, Dept Clin Pharmacol, Basel, Switzerland F Hoffmann La Roche & Co Ltd Basel Switzerland acol, Basel, Switzerland
Titolo Testata:
CLINICAL NEUROPHARMACOLOGY
fascicolo: 2, volume: 24, anno: 2001,
pagine: 82 - 90
SICI:
0362-5664(200103/04)24:2<82:MTPAPO>2.0.ZU;2-8
Fonte:
ISI
Lingua:
ENG
Soggetto:
HEALTHY-SUBJECTS; INSOMNIA; BENZODIAZEPINES; ZOLPIDEM; UPDATE; PHARMACOLOGY; PERFORMANCE; ZALEPLON; EFFICACY;
Keywords:
Ro 41-3696; hypnotic; quinolizinone; tolerability; pharmacokinetics; elderly subjects; metabolism; psychomotor performance;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
38
Recensione:
Indirizzi per estratti:
Indirizzo: Dingemanse, J Buchenstr 2, CH-4103 Bottmingen, Switzerland Buchenstr 2 Bottmingen Switzerland CH-4103 en, Switzerland
Citazione:
J. Dingemanse et al., "Multiple-dose tolerability, pharmacodynamics, and pharmacokinetics of the quinolizinone hypnotic Ro 41-3696 in elderly subjects", CLIN NEUROP, 24(2), 2001, pp. 82-90

Abstract

The objectives of this double-blind, placebo-controlled study were to assess the multiple-dose tolerability, pharmacodynamics, and pharmacokinetics of the hypnotic agent Ro 41-3696 in elderly men and women (55-75 y of age). On day 1 and days 3-8, doses of 1, 3, 5, and 10 mg were administered sequentially to 4 groups of IO subjects, 2 of whom received placebo. Psychomotor performance tests (tracking and attention) were conducted just before and at 1,5,4, and 8 hours after drug intake on days i, 4, 6, and 8. Memory was assessed at 24 hours after drug intake on days 1 and 8 by recall of a list of 10 words, which had been learned at 2 hours after intake. Po 41-3696 was well tolerated at all dose levels. One subject dropped out of the study because of a hypersensitive skin reaction during treatment with 10 mg. Performance in both a tracking test and a memory search test was significantly affected by a dose of 10 mg and moderately affected by doses of 3 and 5 mg. The results of the I-mg dose were indistinguishable from those of placebo. Long-term memory, as assessed by a word learning and recall test, showed the same pattern. Partial tolerance to the impairing effects in the psychometric tests developed over the course of treatment. Pharmacokinetics of both Po41-3696 and its O-desethyl metabolite Ro 41-3290 were dose proportional and time independent. Ro 41-3696 was absorbed and eliminated rapidly (time ofmaximum plasma concentration, approximately 1 hour; elimination half-life,approximately 2 hours). Plasma levels of Po 41-3290 were higher than thoseof the parent drug, and it was more slowly eliminated (values for time of maximum plasma concentration and elimination half-life, approximately 2 andapproximately 7 hours, respectively).

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 23/01/20 alle ore 03:57:19