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The objectives of this study were:
- to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition;
- to assess the controlled release properties of the two prototype formulations;
- to select a prototype formulation for further development;
- to validate the blood sampling schedule for future pivotal pharmacokinetic studies;
- to determine the appropriate sample size for pivotal studies based in the intra-subject variability.
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Trazodone HCl, Trazodone HCl, Trazodone HCl, Trazodone HCl
Published on BioPortfolio: 2014-08-27T03:13:46-0400
The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when ad...
The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contram...
The present study has been designed to evaluate the effect of three doses of trazodone (20, 60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers. Trazodon...
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The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the tre...
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Environmental contamination with pharmaceuticals has received growing attention in recent years. Several studies describe the presence of traces of drugs in water bodies and soils and their impacts on...
P-glycoprotein, encoded by ABCB1, is an ATP-dependent drug efflux pump which exports substances outside the cell. Some studies described connections between C3435T polymorphism T allele and lower P-gl...
We present a case of priapism in a homeless patient with a psychiatric history of major depression, PTSD, polysubstance abuse (alcohol and cocaine) and past psychotropic medication use who was admitte...
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A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.
Dietary patterns which have been found to be important in reducing disease risk.
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