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Titolo:
Bioequivalence of two tablet formulations of atenolol after single oral administration in healthy volunteers
Autore:
Niopas, I; Daftsios, AC; Xanthakis, I; Nikolaidis, N; Njau, SN;
Indirizzi:
Aristotelian Univ Salonika, Dept Pharm, GR-54006 Salonika, Greece Aristotelian Univ Salonika Salonika Greece GR-54006 006 Salonika, Greece Amer Farm Sch Thessaloniki, Anal Pharmacochem Prod, Salonika, Greece Amer Farm Sch Thessaloniki Salonika Greece ochem Prod, Salonika, Greece Aristotelian Univ Salonika, Sch Med, Lab Forens Med & Toxicol, GR-54006 Salonika, Greece Aristotelian Univ Salonika Salonika Greece GR-54006 006 Salonika, Greece
Titolo Testata:
ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH
fascicolo: 3, volume: 50, anno: 2000,
pagine: E243 - E247
SICI:
0004-4172(200003)50:3<E243:BOTTFO>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Keywords:
atenolol; Azectol (R), bioavailability, bioequivalence, clinical pharmacokinetics; beta-blockers; CAS 29122-68-7;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
8
Recensione:
Indirizzi per estratti:
Indirizzo: Niopas, I Aristotelian Univ Salonika, Dept Pharm, GR-54006 Salonika, Greece Aristotelian Univ Salonika Salonika Greece GR-54006 ka, Greece
Citazione:
I. Niopas et al., "Bioequivalence of two tablet formulations of atenolol after single oral administration in healthy volunteers", ARZNEI-FOR, 50(3), 2000, pp. E243-E247

Abstract

The pharmacokinetic parameters of two oral formulations of 100 mg tablets of atenolol (CAS 29122-68-7; Azectol(R) as test and another commercially available preparation as reference) were compared in an open-label, randomized, single oral dose, two-period cross-over design to 17 healthy volunteers under fasting conditions. Serial blood samples were collected prior to eachadministration and at 17 points within 36 h after dosing. Plasma concentrations of atenolol were measured by a validated HPLC assay with fluorometricdetection. The parametric 90 % confidence intervals of the geometric mean values of the test/reference ratios were 94.4 % to 112.9 % (point estimate:103 %) for AUC(0-infinity) 93.7 % to 112.8 % (point estimate: 103 %) for AUC(0-36), and 88.3 % to 112.1 % (point estimate: 100 %) for C-max, within the acceptance criteria for bioequivalence (80 %-125 %). T-max values were analyzed by the nonparametric Wilcoxon test and the difference was not statistically significant. Therefore, it is concluded that the test and reference atenolol formulations are bioequivalent for both the extent and the rate of absorption.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/11/20 alle ore 15:07:42