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Titolo:
Relative bioavailability study of two nifedipine tablet formulations in healthy male volunteers
Autore:
Niopas, I; Daftsios, AC; Xanthakis, I; Nikolaidis, N;
Indirizzi:
Aristotelian Univ Salonika, Sch Hlth Sci, Dept Pharm, GR-54006 Salonika, Greece Aristotelian Univ Salonika Salonika Greece GR-54006 006 Salonika, Greece Amer Farm Sch Thessaloniki, Analyses Pharmaco Chem Prod, Salonika, Greece Amer Farm Sch Thessaloniki Salonika Greece Chem Prod, Salonika, Greece
Titolo Testata:
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
fascicolo: 6, volume: 38, anno: 2000,
pagine: 309 - 314
SICI:
0946-1965(200006)38:6<309:RBSOTN>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
GAS-CHROMATOGRAPHY; SINGLE; BIOEQUIVALENCE;
Keywords:
nifedipine; bioavailability; bioequivalence; clinical pharmacokinetics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
20
Recensione:
Indirizzi per estratti:
Indirizzo: Niopas, I Aristotelian Univ Salonika, Sch Hlth Sci, Dept Pharm, GR-54006 Salonika, Greece Aristotelian Univ Salonika Salonika Greece GR-54006 ka, Greece
Citazione:
I. Niopas et al., "Relative bioavailability study of two nifedipine tablet formulations in healthy male volunteers", INT J CL PH, 38(6), 2000, pp. 309-314

Abstract

Objective: To assess the bioequivalence of two oral formulations containing 10 mg of nifedipine. The test preparation were Macorel tablets, the reference preparation were Adalat tablets. Subjects, material and methods: The study was designed as a single-dose, three-period crossover randomized design to 18 non-smoker, healthy male volunteers under fasting conditions. Seventeen volunteers completed the study. Plasma samples were analyzed for nifedipine by HPLC after solid-phase extraction. The pharmacokinetic parameters used to assess the bioequivalence of the two formulations were AUC(0-infinity), and AUC(0-t) for the extent of absorption and C-max and T-max for the rate of absorption. Statistical comparisons of AUC(0-infinity),, AUC(0-t) and C-max data were evaluated after logarithmic transformation by two-way analysis of variance (ANOVA),and differences of T-max were tested non-parametricaly. Results: Point estimates (90% confidence intervals) of the test/reference ratios were 97.4% (87.6% - 108.3%) for AUC(0-infinity) 97.0% (85.6% - 110.1%) for AUC(0-t), and 107.7% (89.1% - 130.7%) for C-max. No statistically significant difference was found for T-max and elimination half-life values. Conclusion: Therefore, in accordance with the European Union bioequivalence requirements, the test and reference nifedipine preparations 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 16:02:53