1. Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis.
- Author
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Jacquemin, E., Hermeziu, B., Kibleur, Y., Friteau, I., Mathieu, D., Le Coz, F., Moyse, D., Gérardin, M., Jacqz-Aigrain, E., and Munck, A.
- Subjects
CYSTIC fibrosis ,GENETIC disorders ,CHOLESTASIS ,ISOPENTENOIDS ,VITAMIN E - Abstract
Purpose: To test bioequivalence of oral vitamin E formulations, water-soluble tocofersolan (test) and water-miscible (reference), in healthy adult volunteers, and their bioavailability in children with chronic cholestasis or cystic fibrosis. Methods: In a two-way open randomized single dose cross-over design, 1200 IU were administered in 12 healthy volunteers and 100 IU/kg in 12 children with chronic cholestasis or cystic fibrosis. Results: In healthy volunteers, formulations were not bioequivalent with a higher exposure to tocofersolan. In cholestatic children tocofersolan bioavailability was significantly higher than reference formulation (maximum plasma concentration: P = 0·008 and AUC: P = 0·0026). Bioavailability was not statistically different in cystic fibrosis. Conclusions: Oral tocofersolan was more bioavailable than the reference formulation in children with chronic cholestasis and similarly bioavailable in cystic fibrosis. Tocofersolan may represent an alternative to painful intramuscular vitamin E injections in chronic cholestasis, or to other oral formulations in cystic fibrosis. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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