Full Text View
Tabular View
No Study Results Posted
Related Studies
Comparative Bioavailability Study of Extended-Release and Immediate-Release Trazodone in Healthy Adult Volunteers
This study has been completed.
First Received: February 6, 2009   Last Updated: March 30, 2009   History of Changes
Sponsors and Collaborators: Labopharm Inc.
Algorithme Pharma Inc
Information provided by: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00839072
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Trazodone HCl
Phase I

Drug Information available for: Trazodone Trazodone hydrochloride
U.S. FDA Resources
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

Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:
  • Rate and extent of exposure [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]

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
Trazodone Contramid OAD: Experimental Drug: Trazodone HCl
300 mg extended-release caplet, single dose
Desyrel: Active Comparator Drug: Trazodone HCl
100 mg immediate-release tablet, dosing q8h

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Availability for entire study period and willingness to adhere to protocol requirements as evidenced by signed informed consent
  • Male or female volunteer, aged between 18 and 45 years inclusively
  • BMI >19 and <30 kg/m2
  • Minimum body weight: 60 kg
  • Clinical laboratory values within normal range, or without clinical significance
  • Healthy according to medical history, clinical laboratory results and physical examination
  • Nonsmoker or ex-smoker

Exclusion Criteria:

  • Significant history of hypersensitivity to trazodone or any related products, or severe hypersensitivity reactions to any drugs
  • Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects
  • Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
  • Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric disease
  • Use of MAO inhibitors within 28 days of day 1 of the study
  • Presence of significant heart disease or disorder according to ECG
  • Seated systolic blood pressure lower than 90 or over 140 mmHg or diastolic blood pressure lower than 50 or over 90 mmHg at screening
  • Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any clinically significant illness in the previous 28 days before day 1 of this study
  • Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, and rifampin), in the previous 28 days before day 1 of this study
  • Females who are pregnant according to a positive serum pregnancy test, or are lactating
  • Females of childbearing potential who refuse to use an acceptable method of contraception from the screening visit and throughout the study
  • Volunteers who took an investigational product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
  • Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc) in the previous 56 days before day 1 of the study
  • Positive urine screening for drugs of abuse
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive results to HIV, HBsAg, or anti-HCV tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839072

Locations
Canada, Quebec
Algorithme Pharma Inc.
Laval, Quebec, Canada, H7V 4B3
Sponsors and Collaborators
Labopharm Inc.
Algorithme Pharma Inc
Investigators
Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
  More Information

No publications provided

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

Keywords provided by Labopharm Inc.:
bioavailability
pharmacokinetics
healthy
crossover
trazodone

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009