Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
Summary
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.
Study Design
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
Trazodone HCl, Trazodone HCl, Trazodone HCl, Trazodone HCl
Status
Completed
Source
Labopharm Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01121913
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Trazodone
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)
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