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Decreased oral availability of cyclosporin A at second administration in humans
Author(s) -
Lee YoungJoo,
Chung SukJae,
Shim ChangKoo
Publication year - 1997
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.1997.t01-1-00599.x
Subject(s) - pharmacokinetics , bioequivalence , crossover study , dosing , medicine , pharmacology , analysis of variance , oral administration , area under the curve , alternative medicine , pathology , placebo
Aims The objective of this study was to determine the extent of period effect on the pharmacokinetics of cyclosporin A (CsA) during consecutive dosing. Methods Sandimmune Neoral ® and Neoplanta ® capsules were administered to twenty‐four healthy Korean male subjects at a single CsA dose of 175 mg in a 2×2 crossover investigation with a 2‐week wash‐out phase. Concentrations of CsA in blood were measured by a r.i.a. method for a period of 48 h. Results The two formulations were found bioequivalent, but analysis of variance (ANOVA) indicated that there is a significant (P<0.01) period effect in AUC(0,last) (area under the blood concentration‐time curve above the assay limit) and C max (maximum blood concentration) between the administrations. A 6 and 9% decrease in the AUC(0,last) and C max , respectively was seen at the second administration. Conclusions This period effect on the pharmacokinetics of CsA may be relevant for the patients who need consecutive administration of the drug.