Int J Clin Pharm Th
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Int J Clin Pharm Th · Oct 2004
Clinical Trial Controlled Clinical TrialTolerability, pharmacokinetics and concentration-dependent hemodynamic effects of oral CF101, an A3 adenosine receptor agonist, in healthy young men.
To assess safety, tolerability, pharmacokinetics and hemodynamic effects of oral CF 101, an A3 adenosine receptor (A3AR) agonist, in healthy men. ⋯ Single oral doses up to 5 mg CF101 and repeated doses up to 4 mg 12-hourly for 7 days were safe and well-tolerated. Multiple-dose CF101 pharmacokinetics were unchanged and predictable from single-dose estimates, and were linearly proportional to dose. Increases in heart rate and neutrophil count were reversible during multiple dosing and were not dose-limiting in the repeat dose study. CF101 warrants further study for its efficacy in treating human disease.
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Int J Clin Pharm Th · Oct 2004
Clinical TrialSerum albumin-adjusted phenytoin levels: an approach for predicting drug efficacy in patients with epilepsy, suitable for developing countries.
The antiepileptic drug phenytoin has a high degree of plasma protein binding. Therefore, total phenytoin levels in plasma are misleading indicators of clinical efficacy. This study was designed to investigate whether serum albumin-adjusted phenytoin levels in Indian patients with epilepsy predict clinical outcome better than total phenytoin levels. ⋯ In patients with serum albumin levels in the hyper- and hypoalbuminemic range, corrected phenytoin levels were better indicators of clinical outcome. In developing countries like India, where estimation of free drug levels is expensive and suitable equipment is not available in most centers, serum albumin-adjusted levels can be used by pharmacologists to predict response and thus assist in clinical decision-making.