𝔖 Bobbio Scriptorium
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PHARMACOKINETICS OF REBOXETINE IN HEALTHY VOLUNTEERS. SINGLE AGAINST REPEATED ORAL DOSES AND LACK OF ENZYMATIC ALTERATIONS

✍ Scribed by C. Pellizzoni; I. Poggesi; N. P. Jørgensen; D. M. F. Edwards; E. Paus; M. Strolin Benedetti

Publisher
John Wiley and Sons
Year
1996
Tongue
English
Weight
568 KB
Volume
17
Category
Article
ISSN
0142-2782

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✦ Synopsis

The pharmacokinetics of reboxetine have been investigated in 12 healthy male volunteers after a single 2mg dose of reboxetine and at steady state, following the last administration of a multiple-dose regimen (2mg twice a day for 54d). Reboxetine was analysed in plasma and urine samples collected up to 72h postdosing using an HPLC method with UV detection. The urinary excretion rate of 6 4hydroxycortisol, used as a marker for cytochrome P450IIIA activity, was also tested, and any possible alteration was correlated to reboxetine plasma levels. The dosing regimen was well tolerated by all subjects. Reboxetine pharmacokinetic parameters, calculated after the single dose using non-compartmental analysis, were in good agreement with those obtained in previous studies. Following the multiple-dosing regimen, no significant deviations from expectation based on linear superposition was observed. The accumulation ratio, based on repeated-dose/single-dose ratios of Cmax, AUC(&12h), and C(12h) was approximately two. A slight rise was recorded for the average excretion rate of 6-~-hydroxycortisol over 48h by the end of treatment; however, the difference was not statistically significant and the mean excretion rates were within the normal reference range. Thus a significant induction of P450IIIA was not indicated.

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