Bioequivalence study of a valsartan tablet and a capsule formulation after single dosing in healthy volunteers using a replicated crossover design.

Two formulations of valsartan (Diovan), 320 mg tablets and marketed 160 mg capsules, were evaluated for bioequivalence after single dosing

Psychometric appraisal of the scale for interpersonal behavior (SIB) in France

The present study was carried out in France to evaluate the reliability and validity of the Scale for Interpersonal Behavior (SIB), a multidimensional measure of difficulty and distress in assertiveness that was originally developed in The Netherlands. This appraisal was conducted with a clinical-sample (N = 166) and a general population sample (N = 150). The clinical series comprised 115 patients with social phobia and 51 patients with personality disorder, 28 of whom were of the avoidant type. Support was found for internal consistency and test-retest reliability of the French SIB.;Compared to:controls, both social phobics and patients with an avoidant personality disorder had significantly lower mean scores on all performance scales and significantly higher ones on:all distress scales, with the social phobics occupying a position in between. Findings in relation to convergent and divergent validity were quite satisfactory. Sensitivity of the French SIE for detecting change was demonstrated in a subgroup of the clinical Ss who had undergone 15 sessions of cognitive;behavioral group therapy for underassertiveness. (C) 1999 Elsevier Science Ltd. All rights reserved

Randomized phase II trial of deferasirox (Exjade, ICL670), a once-daily, orally-administered iron chelator, in comparison to deferoxamine in thalassemia patients with transfusional iron overload

Background and Objectives. Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. Deferoxamine (Desferal((R)), DFO) reduces morbidity and mortality although the administration schedule of slow, parenteral infusions several days each week limits compliance and negatively affects long-term outcome. Deferasirox (Exjade((R)), ICL670) is an oral chelator with high iron-binding potency and selectivity. In a phase 11 study, the tolerability and efficacy of deferasirox were compared with those of DFO in 71 adults with transfusional hemosiderosis. Design and Methods. Patients were randomized to receive once-daily deferasirox (10 or 20 mg/kg; n=24 in both groups) or DFO (40 mg/kg, 5 days/week; n=23) for 48 weeks. Results. Both treatments were well tolerated and no patient discontinued deferasirox due to drug-related adverse events. The reported frequency of transient, mild to moderate gastrointestinal disturbances was higher in the deferasirox group than in the DFO group, but these disturbances settled spontaneously without dose interruption in all patients. Decreases in liver iron concentration (LIC) were comparable in the deferasirox 20 mg/kg/day and DFO groups; baseline values of 8.5 and 7.9 mg Fe/g dw fell to 6.6 and 5.9 mg Fe/g dw, respectively, by week 48. Deferasirox showed a plasma elimination half-life of 8-16 hours, supporting its once-daily administration. Interpretation and Conclusions. Deferasirox at daily doses of 10 or 20 mg/kg was well tolerated and, at 20 mg/kg, showed similar efficacy to DFO 40 mg/kg in terms of decreases in LIC

Effect of dronedarone on renal function in healthy subjects

What is already known about this subjectCreatinine clearance (CL) is used to assess glomerular filtration rate (GFR). However, it is known to slightly overestimate the true GFR, due to renal tubular secretion of creatinine.During phase I-III clinical trials, a 10–15% increase in serum creatinine has been observed both in healthy subjects and patients receiving the new antiarrhythmic agent dronedarone.What this study addsDronedarone affects the renal handling of creatinine and N-methylnicotinamide, two cations, while leaving unchanged GFR, assessed through sinistrin CL, and renal plasma flow and anion secretion, assessed through para-amino-hippurate CL.This suggests a specific action of dronedarone on renal organic cation transport explaining the limited, reversible effect of dronedarone on serum creatinine, which must not be interpreted as reflecting an impairment of renal function, but which may indicate an interaction potential with cationic drugs