NCT00839072

Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers

Crossover Comparative Bioavailability Study of Trazodone Contramid(r) OAD 300 mg Extended-release Caplets and Desyrel(r) 100 mg Immediate-release Tablets in Healthy Adult Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Detailed description

The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trazodone HCl	100 mg immediate-release tablet, dosing q8h
DRUG	Trazodone HCl	300 mg extended-release caplet, single dose

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2009-02-09
• Last updated: 2012-04-27
• Results posted: 2010-08-16

Locations

1 site across 1 country: Canada