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Titolo:
Relative bioavailability of two isosorbide dinitrate sublingual tablet formulations administered as single doses in healthy subjects
Autore:
Niopas, I; Daftsios, AC; Nikolaidis, N;
Indirizzi:
Aristotelian Univ Thessaloniki, Sch Hlth Sci, Dept Pharm, GR-54006 Thessaloniki, Greece Aristotelian Univ Thessaloniki Thessaloniki Greece GR-54006niki, Greece Amer Farm Sch Thessaloniki, Analyses Pharmaco Chem Prod, Thessaloniki, Greece Amer Farm Sch Thessaloniki Thessaloniki Greece od, Thessaloniki, Greece
Titolo Testata:
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
fascicolo: 5, volume: 39, anno: 2001,
pagine: 224 - 228
SICI:
0946-1965(200105)39:5<224:RBOTID>2.0.ZU;2-V
Fonte:
ISI
Lingua:
ENG
Soggetto:
PHARMACOKINETICS; METABOLITES; PLASMA;
Keywords:
isosorbide dinitrate; isosorbide 5-mononitrate; bioavailability; bioequivalence; clinical pharmacokinetics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
14
Recensione:
Indirizzi per estratti:
Indirizzo: Niopas, I Aristotelian Univ Thessaloniki, Sch Hlth Sci, Dept Pharm, GR-54006 Thessaloniki, Greece Aristotelian Univ Thessaloniki Thessaloniki Greece GR-54006 ce
Citazione:
I. Niopas et al., "Relative bioavailability of two isosorbide dinitrate sublingual tablet formulations administered as single doses in healthy subjects", INT J CL PH, 39(5), 2001, pp. 224-228

Abstract

Objective: The purpose of this study was to evaluate the relative bioavailability and bioequivalence of a test and a reference sublingual tablet eachcontaining 5 mg of isosorbide dinitrate in healthy volunteers. Methods: The study was conducted as an open-label, randomized, single-dose, two-periodcrossover design in 20 healthy volunteers with a washout period of 7 days,under fasting conditions. Plasma concentrations of the major active metabolite isosorbide 5-mononitrate were quantified, using a validated capillary gas chromatographic assay, with electron-capture detection. The pharmacokinetic parameters used to assess the bioequivalence of the two preparations were AUC(0-infinity) and AUC(0-t) for the extent of absorption and C-max andt(max) for the rate of absorption. Results: The calculated 90% confidence intervals of the geometric mean values of the test/reference ratios were 98.2% to 103.2% (point estimate; 100.7%) for AUC(0-infinity) 96.9% to 103.8% (point estimate; 100.3%) for AUC(0-t) and 87.9% to 98.2% (point estimate; 92.9%) for C-max. No statistically significant difference was found for tm, and elimination half-life (t(1/2)) values. Conclusion: From the results of the present study, it is concluded that the test and reference isosorbide dinitrate sublingual preparations are bioequivalent in both extent and rate of absorption and it can be assumed that they are therapeutically equivalent and exchangeable in clinical practice.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 05/12/20 alle ore 07:33:29