| Download ( PDF | 212kB) |
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.
Alternative Links zum Volltext
Beteiligte Einrichtungen
Details
| Dokumentenart | Artikel | ||||
| Titel eines Journals oder einer Zeitschrift | Naunyn-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 | ||||
| Datum | 2007 | ||||
| Institutionen | Chemie 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 |
| ||||
| Stichwörter / Keywords | GENERIC 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-Klassifikation | 500 Naturwissenschaften und Mathematik > 540 Chemie | ||||
| Status | Veröffentlicht | ||||
| Begutachtet | Ja, diese Version wurde begutachtet | ||||
| An der Universität Regensburg entstanden | Unbekannt / Keine Angabe | ||||
| URN der UB Regensburg | urn:nbn:de:bvb:355-epub-26657 | ||||
| Dokumenten-ID | 2665 |
Downloadstatistik
Downloadstatistik