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Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers

2014-08-27 03:13:46 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

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