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Kees, F. ; Bucher, M. ; Schweda, F. ; Gschaidmeier, H. ; Faerber, L. ; Seifert, R.

Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of Neoimmun

Kees, F., Bucher, M., Schweda, F., Gschaidmeier, H., Faerber, L. und Seifert, R. (2007) Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of Neoimmun. Naunyn-Schmiedeberg's Archives of Pharmacology 375 (6), S. 393-399.

Veröffentlichungsdatum dieses Volltextes: 05 Aug 2009 13:40
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.2665


Zusammenfassung

In two crossover studies with 12 (6 males/6 females) healthy young volunteers each, we compared the bioavailability of Neoimmun capsules with the microemulsion Neoral and the influence of a fat-rich breakfast on the bioavailability of Neoimmun. Each volunteer received a single dose of 200 mg cyclosporine A in each period. Blood samples were taken up to 24 h and analysed for cyclosporine A by ...

In two crossover studies with 12 (6 males/6 females) healthy young volunteers each, we compared the bioavailability of Neoimmun capsules with the microemulsion Neoral and the influence of a fat-rich breakfast on the bioavailability of Neoimmun. Each volunteer received a single dose of 200 mg cyclosporine A in each period. Blood samples were taken up to 24 h and analysed for cyclosporine A by high-performance liquid chromatography (HPLC) and photometric detection. The pharmacokinetic parameters were determined by non-compartmental analysis. The treatments were tested for bioequivalence and significant differences. The bioavailability of Neoimmun was significantly lower compared to Neoral, albeit Neoimmun met the bioequivalence criterion (90% confidence interval of AUC 0.80-0.94) or missed the criterion only marginally (90% confidence interval of c(max) 0.75-0.91). The bioavailability of Neoimmun as determined by area under the blood concentration-time curve (AUC) increased by nearly 20% after a fat-rich breakfast. However, mean peak concentrations after food were only higher in male subjects, whereas mean peak concentrations in female subjects were lower compared to fasting administration. In conclusion, our data show that Neoimmun exhibits a lower bioavailability than the microemulsion Neoral and that food has a significant but variable and sex-dependent impact on the bioavailability of Neoimmun capsules.



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Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftNaunyn-Schmiedeberg's Archives of Pharmacology
Verlag:SPRINGER
Ort der Veröffentlichung:NEW YORK
Band:375
Nummer des Zeitschriftenheftes oder des Kapitels:6
Seitenbereich:S. 393-399
Datum2007
InstitutionenChemie und Pharmazie > Institut für Pharmazie > Lehrstuhl Pharmakologie und Toxikologie (Prof. Schlossmann, ehemals Prof. Seifert)
Chemie und Pharmazie > Institut für Pharmazie > Lehrstuhl Pharmakologie und Toxikologie (Prof. Schlossmann, ehemals Prof. Seifert)
Identifikationsnummer
WertTyp
10.1007/s00210-007-0169-3Nicht ausgewählt
Stichwörter / KeywordsGENERIC CYCLOSPORINE FORMULATIONS; RENAL-TRANSPLANT RECIPIENTS; PHARMACOKINETIC CONSIDERATIONS; MONITORING CYCLOSPORINE; ORGAN-TRANSPLANTATION; CLINICAL-IMPLICATIONS; DRUG; THERAPY; SUBSTITUTION; ESTRADIOL; Cyclosporine A; food effect; bioavailability; bioequivalence; gender effect
Dewey-Dezimal-Klassifikation500 Naturwissenschaften und Mathematik > 540 Chemie
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenUnbekannt / Keine Angabe
URN der UB Regensburgurn:nbn:de:bvb:355-epub-26657
Dokumenten-ID2665

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