Clinical therapeutics
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Comparative StudyA new esomeprazole packet (sachet) formulation for suspension: in vitro characteristics and comparative pharmacokinetics versus intact capsules/tablets in healthy volunteers.
A packet (sachet) formulation of esomeprazole for suspension has been developed for use in patients who have difficulty swallowing. ⋯ In these analyses, the packet (sachet) formulation of esomeprazole was chemically stable in suspension and when administered orally and via enteral tubes. The formulation had a short reconstitution time, remaining fully dispersed in water for at least 30 minutes, and was dispersed in applesauce, apple juice, or orange juice without compromising its stability or dispersion characteristics. The packet formulation met the regulatory definition for bioequivalence to the tablet and capsule formulations.
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Comparative StudyMetabolic and antihypertensive effects of moxonidine and moxonidine plus irbesartan in patients with type 2 diabetes mellitus and mild hypertension: a sequential, randomized, double-blind clinical trial.
The autonomic nervous system plays an important part in the homeostasis of blood pressure (BP), and sympathetic overactivity may contribute to metabolic conditions such as glycemic intolerance or insulin resistance. ⋯ In these patients with type 2 diabetes and mild hypertension, the M0.4 group had greater improvements in measures of glucose metabolism and the plasma lipid profile compared with those treated with M0.2+1.
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Multicenter StudyEfficacy and tolerability of intravenous continuous erythropoietin receptor activator: a 19-week, phase II, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease.
A continuous erythropoietin receptor activator (C.E.R.A.) is currently in development for the treatment of anemia in patients with chronic renal disease (CRD) receiving or not receiving dialysis treatment. ⋯ In this study, N C.E.R.A. provided effective maintenance of Hb concentrations in patients receiving dialysis treatment who were switched directly from N epoetin alfa TIW to N C.E.R.A. QW or Q2W C.E.R.A. was generally well tolerated.
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Comparative StudyRelative bioavailability of tizanidine 4-mg capsule and tablet formulations after a standardized high-fat meal: a single-dose, randomized, open-label, crossover study in healthy subjects.
An immediate-release, multiparticulate capsule formulation of tizanidine has been developed to modify tizanidine pharmacokinetic characteristics in an attempt to decrease adverse events (AEs) while maintaining effectiveness in the management of spasticity. ⋯ In this small study in healthy volunteers, after a single oral dose was administered following a high-fat meal, the mean C(max) was significantly lower and mean T(max) was significantly longer with the capsule formulation of tizanidine compared with the tablet. The capsule formulation was found not to be bioequivalent to the tablet when given with food. Based on these findings, caution is needed when a patient is switched between the capsule and tablet formulations of tizanidine, or when the timing of administration of either formulation is changed in relation to food ingestion.
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Clinical therapeutics · Apr 2007
Randomized Controlled TrialA phase I, randomized, open-label, crossover study of the single-dose pharmacokinetic properties of guanfacine extended-release 1-, 2-, and 4-mg tablets in healthy adults.
Guanfacine is an alpha(2)-adrenoreceptor agonist used to treat children and adults with attention-deficit/hyperactivity disorder. An extended-release formulation of guanfacine is currently under development. ⋯ In these 49 healthy adult subjects, the single-dose pharmacokinetic properties of GXR 1-, 2-, and 4-mg tablets appeared to be statistically linear; that is, increases in mean C(max), AUC(0-t), and AUC(0-infinity) of guanfacine were proportional to dose, with the exception of the increase in mean C(max) between GXR 1 and 2 mg. All doses appeared to be well tolerated, with no serious AEs or withdrawal or discontinuation from study participation due to AEs reported.