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Titolo:
Bioequivalence between omeprazole MUPS 20 mg as tablet and omeprazole MUPS20 mg as tablet encapsulated in a hard gelatine capsule
Autore:
Schaltenbrand, R; Huber, R; Cotoraci, CA; Mascher, H; Potthast, H; Hole, U;
Indirizzi:
Univ Witten Herdecke, Inst Res & Dev, D-58455 Witten, Germany Univ Witten Herdecke Witten Germany D-58455 Dev, D-58455 Witten, Germany BYK Gulden Lomberg GmbH, D-7750 Constance, Germany BYK Gulden Lomberg GmbH Constance Germany D-7750 7750 Constance, Germany Univ Vest Vasile Goldis, Arad, Romania Univ Vest Vasile Goldis Arad Romania Vest Vasile Goldis, Arad, Romania Pharm Analyt GMBH, Baden, Switzerland Pharm Analyt GMBH Baden Switzerland arm Analyt GMBH, Baden, Switzerland Zent Lab Deutsch Apotheker, Eschborn, Germany Zent Lab Deutsch Apotheker Eschborn Germany potheker, Eschborn, Germany
Titolo Testata:
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
fascicolo: 10, volume: 39, anno: 2001,
pagine: 453 - 459
SICI:
0946-1965(200110)39:10<453:BBOM2M>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
PROTON PUMP INHIBITORS; PHARMACOKINETICS; PHARMACODYNAMICS; BIOAVAILABILITY; SINGLE;
Keywords:
omeprazole; bioequivalence; proton pump inhibitor; pharmacokinetics; healthy subjects;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
31
Recensione:
Indirizzi per estratti:
Indirizzo: Schaltenbrand, R Univ Witten Herdecke, Inst Res & Dev, Alfred Herrhausen Str 44, D-58455 Witten, Germany Univ Witten Herdecke Alfred Herrhausen Str 44 Witten Germany D-58455
Citazione:
R. Schaltenbrand et al., "Bioequivalence between omeprazole MUPS 20 mg as tablet and omeprazole MUPS20 mg as tablet encapsulated in a hard gelatine capsule", INT J CL PH, 39(10), 2001, pp. 453-459

Abstract

Aims: To investigate pharmacokinetic characteristics of omeprazole MUPS 20mg tablets and its encapsulated form. Material and methods: Bioequivalenceof omeprazole MUPS 20 mg tablet (Reference) and omeprazole MUPS 20 mg tablet in a hard gelatine capsule (Test) was evaluated in a randomized, 2-period crossover study in 38 healthy male Caucasian subjects who received a single oral dose of 20 mg omeprazole in each study period. Serum concentrationsof omeprazole MUPS 20 mg were measured using an HPLC assay. In addition, in vitro dissolution profiles were studied. Results: Both formulations were bioequivalent as assessed by the primary pharmacokinetic characteristics AUC(0-infinity) and C-max, the corresponding ratios (Test/Reference) being 0.97 and 0.98, respectively. Thus, the 90% CI of these ratios were within theequivalence range of 0.8 to 1.25 for AUC(0-infinity) (CI 0.90 - 1.04) and 0.67 to 1.50 for C-max (CI 0.86 - 1. 10). The ratios of the secondary criteria, C-max/AUC(0-infinity) and t(1/2), were also within the equivalence range. Median tma, of Reference and Test was identical. Both formulations revealed comparable dissolution profiles with high batch conformity and homogeneity releasing > 80% omeprazole within I hour. Both study formulations werewell tolerated without relevant differences. Conclusion: The encapsulationof omeprazole MUPS 20 mg tablets does not influence the extent and rate ofabsorption as indicated by the AUC and C-max ratios. Thus, bioequivalence could be demonstrated.

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Documento generato il 22/01/20 alle ore 18:39:00