European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jun 2005
Randomized Controlled Trial Comparative StudyThe effects of tramadol on static and dynamic pupillometry in healthy subjects--the relationship between pharmacodynamics, pharmacokinetics and CYP2D6 metaboliser status.
The main objective of the present study was to provide information on whether static and dynamic pupillometry can be used for pharmacodynamic profiling, particularly when investigating opioid-like drugs, such as tramadol. ⋯ The EMs and PMs of CYP2D6 treated with tramadol behaved differently in static and dynamic pupillometry. The reason for this could largely be explained with the aid of the metaboliser status and the pharmacokinetic properties of tramadol. In EMs, the pupillometric response was mainly driven by the (+)-M1, which comprises the mu action component of tramadol; whereas, in PMs, the non-mu component appears to play an important role. Thus, pupillometry was found to be useful in pharmacodynamic profiling and provides a good correlation with the pharmacokinetics.
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Eur. J. Clin. Pharmacol. · Jun 2005
Randomized Controlled Trial Clinical TrialThe effect of mild and moderate hepatic impairment on the pharmacokinetics of valdecoxib, a selective COX-2 inhibitor.
This study evaluated the effects of varying degrees of hepatic impairment on the pharmacokinetics and safety of valdecoxib following single and multiple dosing. ⋯ In our small study sample, mild and moderate hepatic impairment appeared to have only a modest effect on valdecoxib and SC-66905 pharmacokinetics. The adjustment of valdecoxib dose or dosing regimen does not appear mandatory in subjects with mild or moderate hepatic impairment, although caution is necessary during treatment of these patients with valdecoxib.