Int J Clin Pharm Th
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Int J Clin Pharm Th · Oct 2009
Randomized Controlled Trial Comparative StudyBioequivalence study of two meloxicam tablet formulations after single-dose administration in healthy Thai male volunteers.
To compare the bioavailability of two meloxicam tablet formulations (MEL-OD, Zydus Cadila Healthcare Limited, India, as a test formulation and Mobic, Boehringer Ingelheim International GmbH, Germany, as a reference formulation) in healthy Thai male volunteers under fasting condition. ⋯ It can be concluded that two meloxicam tablet formulations are bioequivalent both in term of rate and extent of absorption after single-dose administration under fasting condition.
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Int J Clin Pharm Th · Oct 2009
Randomized Controlled Trial Comparative StudyBioequivalence study of low-dose diclofenac potassium tablet formulations.
Diclofenac is a nonsteroidal antiinflammatory drug with potent analgesic and anti-inflammatory properties. An immediate-release formulation containing a low dose of 12.5 mg diclofenac-potassium (-K) is marketed as over the counter (OTC) medication in most European countries. An immediate-release formulation containing 25 mg diclofenac-K has now also been approved for OTC use. This study assessed the bioequivalence of two immediate-release diclofenac formulations when administered at the same dose. ⋯ The two diclofenac-K immediate release formulations were pharmacokinetically similar. It can be concluded that the new sugar-coated tablet formulation is equivalent to the available film-coated tablet formulation with respect to the extent of diclofenac absorption.
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Int J Clin Pharm Th · May 2009
Randomized Controlled Trial Comparative StudyDeferasirox does not induce QT/QTc-prolongation in healthy subjects.
The International Conference on Harmonization (ICH) E14 guidance recommends that almost all drugs should undergo careful clinical testing in a thorough QT/QTc study. Deferasirox (Exjade, ICL670) is a once-daily oral iron chelator, developed for the treatment of blood transfusion-related iron overload. ⋯ This study demonstrates that deferasirox does not prolong the QT/QTc interval at both therapeutic and supratherapeutic plasma concentrations. It is, therefore, not expected that deferasirox has a negative effect on cardiac repolarization in patients under treatment with this medication.
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Int J Clin Pharm Th · Feb 2009
Randomized Controlled Trial Comparative StudyInflammatory response to cardiopulmonary bypass with enoximone or steroids in patients undergoing myocardial revascularization: a preliminary report study.
Recent reports have showed an antiinflammatory effect of phosphodiesterase III inhibitors (PDEi) in patients undergoing cardiopulmonary bypass (CPB). We sought to evaluate the immunological and hemodynamic response to enoximone and methylprednisolone in patients undergoing CABG. ⋯ Despite comparable major clinical endpoints enoximone showed a different antiinflammatory pattern compared to methylprednisolone, however, the better hemodynamic response in enoximone compared to methylprednisolone suggests enoximone as a potential antiinflammatory tool to improve the outcome in cardiac surgery.
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Int J Clin Pharm Th · Sep 2008
Randomized Controlled TrialPopulation pharmacokinetics study of remifentanil in Chinese adult patients determined by an LC-MS/MS method.
The aim of this study was to construct the population pharmacokinetic model in Chinese adult patients and to characterize the factors that affect the parameters of remifentanil pharmacokinetics. ⋯ The LC-MS/MS method for the quantification of remifentanil in human whole blood was rapid, selective and highly sensitive. The population model was acceptable and would be helpful for clinicians to assess the remifentanil pharmacokinetic parameters based on patient's specific demographic characteristics.