Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
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
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01121913
- Information obtained from ClinicalTrials.gov on July 15, 2010
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 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...
Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpat...
Rationale: A low respiratory arousal threshold is a physiological trait involved in obstructive sleep apnea(OSA) pathogenesis. Trazodone may increase arousal threshold without compromising upper airwa...
Objective-To investigate the safety and efficacy of oral administration of the serotonin antagonist and reuptake inhibitor trazodone hydrochloride to facilitate confinement and calming after orthopedi...
Introduction: Sleep-promoting antidepressants are of interest because they are used not only as antidepressants, but also to promote sleep. Methods: We reviewed case reports describing the switch to m...
Context. 4-Fluoroamphetamine (4-FA) is a para-substituted phenethylamine-type synthetic stimulant that has in recent years gained popularity through internet blogs and market share according to confis...
Medical and Biotech [MESH] Definitions
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)