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Sponsors and Collaborators: |
Labopharm Inc. Algorithme Pharma Inc |
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Information provided by: | Labopharm Inc. |
ClinicalTrials.gov Identifier: | NCT00839072 |
The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
Condition | Intervention | Phase |
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Healthy |
Drug: Trazodone HCl |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study |
Official Title: | 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 |
Estimated Enrollment: | 24 |
Study Start Date: | February 2009 |
Study Completion Date: | March 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Trazodone Contramid OAD: Experimental |
Drug: Trazodone HCl
300 mg extended-release caplet, single dose
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Desyrel: Active Comparator |
Drug: Trazodone HCl
100 mg immediate-release tablet, dosing q8h
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Labopharm Inc ( David Karhu/Director, Pharmacokinetics ) |
Study ID Numbers: | 04ACL1-011, TAN-P8-681 |
Study First Received: | February 6, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00839072 History of Changes |
Health Authority: | Canada: Health Canada |
bioavailability pharmacokinetics healthy crossover trazodone |
Neurotransmitter Agents Tranquilizing Agents Trazodone Psychotropic Drugs Central Nervous System Depressants Anti-Anxiety Agents |
Healthy Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Antidepressive Agents Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Trazodone Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Anti-Anxiety Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |