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Titolo:
Relative bioavailability of two enteric-coated formulations of omeprazole following repeated doses in healthy volunteers
Autore:
Vaz-da-Silva, M; Hainzl, D; Almeida, L; Dolgner, A; Silveira, P; Maia, J; Soares-da-Silva, P;
Indirizzi:
Labs Bial, Dept Res & Dev, Human Pharmacol Unit, P-4745457 S Mamede Do Coronado, Portugal Labs Bial S Mamede Do Coronado Portugal P-4745457 Do Coronado, Portugal Labs Bial, Dept Res & Dev, Lab Pharmacol Res, P-4745457 S Mamede Do Coronado, Portugal Labs Bial S Mamede Do Coronado Portugal P-4745457 Do Coronado, Portugal
Titolo Testata:
CLINICAL DRUG INVESTIGATION
fascicolo: 3, volume: 21, anno: 2001,
pagine: 203 - 210
SICI:
1173-2563(2001)21:3<203:RBOTEF>2.0.ZU;2-M
Fonte:
ISI
Lingua:
ENG
Soggetto:
ORAL PHARMACOKINETICS; BIOEQUIVALENCE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
11
Recensione:
Indirizzi per estratti:
Indirizzo: Almeida, L Labs Bial, Dept Res & Dev, Human Pharmacol Unit, P-4745457 S Mamede Do Coronado, Portugal Labs Bial S Mamede Do Coronado Portugal P-4745457 o, Portugal
Citazione:
M. Vaz-da-Silva et al., "Relative bioavailability of two enteric-coated formulations of omeprazole following repeated doses in healthy volunteers", CLIN DRUG I, 21(3), 2001, pp. 203-210

Abstract

Objective: This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. Design and Study Participants: The study formulation (Ompranyt (R) 20mg capsules, Bial-Industrial Farmaceutica SA, Spain) was compared with an omeprazole reference formulation (Mopral (R) 20mg capsules, Laboratorio Astra, Spain). 24 participants were randomised using a two-way, crossover design to receive either one capsule/day of Ompranyt (R) or one capsule/day of Mopral(R) during two sequential periods of five consecutive days each. The participants were administered the drugs in the fasting state. Omeprazole concentrations in plasma samples were quantified by a validated method using a reversed-phase high performance liquid chromatography with UV detection (HPLC-UV). The validation method is described. Setting: The study was conducted at the Human Pharmacology Unit, Department of Research & Development, Laboratories Bial (S. Mamede do Coronado, Portugal). Results: The arithmetic mean +/- SD values of the area under the plasma concentration Versus time curve from time zero to infinity (AUC(0-infinity),)were 1474 +/- 1417 mug/L .h for Ompranyt (R) and 1490 +/- 1276 mug/L .h for Mopral (R). The geometric means ratio (Ompranyt (R) /Mopral (R)) was 0.99, with 90% confidence intervals (CI) of 0.97-1.03. The estimated maximum plasma concentration (C-max) was 630.1 +/- 516.7 mug/L for Ompranyt (R) and 736.7 +/- 443.3 mug/L for Mopral (R), with a geometric means ratio (Ompranyt(R) /Mopral (R)) of 0.96 (90% CI: 0.94-0.99). Bioequivalence of these two formulations was accepted based on the two one-sided ANOVA for AUC(0-infinity) as well as for Cmax. In both cases, the 90% CI lies within the acceptance range of 0.80-1.25. Conclusion: Bioequivalence of Ompranyt (R) and Mopral (R) was demonstratedafter repeated drug administration in fasting conditions, and both products were similarly well tolerated. Therefore, both formulations are expected to be equivalent in a clinical setting.

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Documento generato il 07/07/20 alle ore 12:32:24