The Effect of Food on the Single ‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine

AbstractDuloxetine is a combined serotonin and norepinephrine reuptake inhibitor indicated in adults for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, and generalized anxiety disorder. The aim of these studies was to evaluate the effect of food on the pharmacokinetics and safety of duloxetine 60 ‐mg gastroresistant hard capsules following single‐dose administration. The data were obtained from 2 phase 1 bioequivalence studies, 1 in a fasting state and the other under fed conditions. Both studies have shown that, when administered as a single dose in the same prandial state, the test and reference duloxetine treatments were bioequivalent and exhibited similar safety profiles. The mean fed and fasting pharmacokinetic parameters and drug‐related adverse events from the 2 studies were compared in order to assess the effect of food on the duloxetine bioavailability and respectively, tolerability. Administration of duloxetine in fed conditions increased peak plasma concentration by up to 30% and delayed mean time to peak concentration by an average of 1.15 hours while having an insignificant effect on extent of absorption (area under the plasma concentration–time curve in fed state within ±6% as compared with fasting conditions). Even though peak plasma levels were substantially higher in the fed state, there was no negative impact on the drug's safety profile. Actually, administration with food resulted in a lower average numb...
Source: Clinical Pharmacology in Drug Development - Category: Drugs & Pharmacology Authors: Tags: Original Manuscript Source Type: research

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Conclusion: Major limitations of the reviewed studies were short trial duration, small sample sizes, and the lack of control groups. Defining the potential role of DUL in the treatment of psychiatric disorders other than major depressive disorder and generalized anxiety disorder needs further randomized, placebo-controlled studies.
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Conclusion: Our results indicate similar prevalence rates of comorbid psychiatric symptoms to studies carried out in the Middle East and North Africa (MENA) region and relatively high attendance and referral rates to psychiatric services.Implications: The results shed light on the clinical profile of patients in this region and support the need for integrated collaborative medical services. Moreover, findings have important implications for health care policies pertaining to resource distribution and funding.IntroductionMedical care has traditionally been dominated by a separation between disciplines catering to physiologi...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Karin Meissner1,2*, Nicola Talsky1, Elisabeth Olliges1,2, Carmen Jacob1,3,4, Oliver J. Stötzer5, Christoph Salat5, Michael Braun6 and Raluca Flondor1 1Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany 2Division of Health Promotion, Coburg University of Applied Sciences, Coburg, Germany 3Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom 4Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom 5Haematology and Oncology, Outpatient Cancer Ca...
Source: Frontiers in Pharmacology - Category: Drugs & Pharmacology Source Type: research
In this study, a link between mitochondrial changes and infant temperament has also been suggested. Maternal psychosocial stress and lifetime trauma have been associated with decreased mitochondrial DNA copy number in the placenta (115, 116).IndividualityChronic stress links changes in the epigenetic landscape with health conditions (117). Different cell types are characterized by distinct patterns of gene expression due to developmental, environmental, physiological, and pathological reasons (117). Epigenetic mechanisms affect gene function in a dynamic way as a result of different environmental exposures during fetal dev...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
This article reviews this relationship and provides recommendations for management. Keywords: Insomnia, sleep disorder, psychiatric disorder, depression, psychosis, schizophrenia, anxiety disorder Insomnia affects 25 million people in the United States annually and leads to an estimated $100 billion health care burden. Insomnia has also been shown to be a causal factor in other medical and psychiatric disorders, cognitive impairments, accidents, absenteeism, and reduced quality of life.1 The cost of not treating insomnia is more than the cost of treating insomnia.2 Insomnia as a symptom is seen in up to one third of the Un...
Source: Innovations in Clinical Neuroscience - Category: Neuroscience Authors: Tags: Current Issue Review anxiety disorder depression insomnia psychiatric disorder psychosis schizophrenia sleep disorder Source Type: research
Conclusions: Nature contact may offer a range of human health benefits. Although much evidence is already available, much remains unknown. A robust research effort, guided by a focus on key unanswered questions, has the potential to yield high-impact, consequential public health insights. https://doi.org/10.1289/EHP1663 Received: 26 January 2017 Revised: 12 May 2017 Accepted: 25 May 2017 Published: 31 July 2017 Address correspondence to H. Frumkin, Dept. of Environmental and Occupational Health Sciences, University of Washington School of Public Health, Box 354695, Seattle, WA 98195-4695 USA; Telephone: 206-897-1723;...
Source: EHP Research - Category: Environmental Health Authors: Tags: Commentary Source Type: research
By Susan Blumenthal, M.D. and Alexandrea Adams The recent commemoration of National Women’s Health Week provided an important time to mark the progress that has been made in advancing women’s health over the past two decades and to highlight what more needs to be done to achieve women’s health equity in America. Historically, women have experienced discrimination in health care despite making 80 percent of health care decisions for their families, using more medical services than men, and suffering greater disability from chronic disease. Before the mid 1990’s, women were often excluded as subjects ...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news
“I have chosen a surreal art approach to represent my invisible disability, due to the surreal nature of mental illness,” tattoo artist Lindsay Carter expressed in a statement. Carter’s image ― featured on the right, above ― shows a bird whose head is a cage with a giant eyeball protruding from the dreamlike vision.  “As long as I’ve been consciously aware, I’ve been diagnosed with generalized anxiety disorder and major depressive disorder,” she continued. “Severe episodes can happen for no apparent reason and at that point I cannot help nor snap out of the...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news
Background: When patients present to the emergency department with a complaint concerning for heart disease, this often becomes the primary focus of their evaluation. While patients with noncardiac causes of chest pain outnumber those with cardiac causes, noncardiac etiologies are frequently overlooked. We investigated symptoms and noncardiac conditions in a cohort of patients with chest pain at low risk of cardiac disease. Methods: We analyzed data from a prospective registry of patients who were evaluated in our chest pain evaluation center. Registry participants completed standardized and validated instruments for depre...
Source: Critical Pathways in Cardiology - Category: Cardiology Tags: Original Articles Source Type: research
Abstract Although trazodone is approved and marketed in most countries worldwide for the sole treatment of Major Depressive Disorder, the use for this medication is very common for many other conditions, such as primary or secondary insomnia, Generalised Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder and Obsessive-Compulsive Disorder. Other, not officially approved, uses of trazodone include: the treatment of bulimia, benzodiazepine and/or alcohol dependence or abuse, fibromyalgia, degenerative diseases of the central nervous system such as dementia and other organic disorders, schizophrenia, chr...
Source: Current Pharmaceutical Design - Category: Drugs & Pharmacology Authors: Tags: Curr Pharm Des Source Type: research
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