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Titolo:
Human bioequivalence study of clarithromycin from two tablet formulations after single oral administration
Autore:
Niopas, I; Daftsios, AC; Nikolaidis, N;
Indirizzi:
Aristotelian Univ Salonika, Sch Hlth Sci, Dept Pharm, Salonika 54006, Greece Aristotelian Univ Salonika Salonika Greece 54006 Salonika 54006, Greece Amer Farm Sch Thessaloniki, Salonika, Greece Amer Farm Sch Thessaloniki Salonika Greece essaloniki, Salonika, Greece
Titolo Testata:
CLINICAL DRUG INVESTIGATION
fascicolo: 3, volume: 21, anno: 2001,
pagine: 211 - 217
SICI:
1173-2563(2001)21:3<211:HBSOCF>2.0.ZU;2-7
Fonte:
ISI
Lingua:
ENG
Soggetto:
HAEMOPHILUS-INFLUENZAE; INVITRO ACTIVITY; PHARMACOKINETICS; VOLUNTEERS; MACROLIDE; A-56268; TE-031;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
17
Recensione:
Indirizzi per estratti:
Indirizzo: Niopas, I Aristotelian Univ Salonika, Sch Hlth Sci, Dept Pharm, Salonika 54006, Greece Aristotelian Univ Salonika Salonika Greece 54006 54006, Greece
Citazione:
I. Niopas et al., "Human bioequivalence study of clarithromycin from two tablet formulations after single oral administration", CLIN DRUG I, 21(3), 2001, pp. 211-217

Abstract

Objective: The objective of this study was to compare the relative bioavailability and bioequivalence of a test (Claromycin (R), GA Pharmaceuticals) and a reference (Klaricid (R), Abbott) tablet containing 500mg clarithromycin in healthy volunteers under fasting conditions. Methods: This was a nonblinded, single-dose, randomised, two-period, crossover study in 16 healthy volunteers conducted under fasting conditions. Plasma samples were analysed for clarithromycin by a validated high performance liquid chromatography assay with electrochemical detection. Results: One volunteer did not receive the reference tablet. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios analysed for 16 participants were 84.2 to 111.6% (point estimate 97.3%) for the area under the plasma concentration-time curve for time zeroto infinity (AUC(0-infinity)), 82.2 to 117.6% (point estimate 98.3 %) for time zero to time t (AUC(0-t)), and 74.4 to 142.9% (point estimate 103.1%) for peak plasma concentration (C-max). No statistically significant differences were found between the formulations for the time to reach C-max (t(max) and elimination half-life values. When the results were analysed for 15 participants, the 90% confidence intervals were 84.1 to 111.9% for AUC(0-infinity), 82.8 to 119.1% for AUC(0-t) and 74.1 to 143.6% for C-max. Conclusions: From the results of this study, it is concluded that the two tablet preparations of clarithromycin are bioequivalent in 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 05/12/20 alle ore 07:50:04