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

This study has been completed.
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00839072
First received: February 6, 2009
Last updated: April 24, 2012
Last verified: April 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:
  • Bioequivalence Based on Cmax [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
    Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)

  • Bioequivalence Based on AUCT [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
    AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration

  • Bioequivalence Based on AUC∞ [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
    AUC∞ = Area under the concentration-time curve extrapolated to infinity


Secondary Outcome Measures:
  • Time of Maximum Measured Plasma Concentration (Tmax) [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent Terminal Elimination Half-Life [T½el] [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
    The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.

  • Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24] [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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
Experimental: Trazodone Contramid OAD Drug: Trazodone HCl
300 mg extended-release caplet, single dose
Other Name: Oleptro
Active Comparator: Desyrel 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 ≥20 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.
ClinicalTrials.gov Identifier: NCT00839072     History of Changes
Other Study ID Numbers: 04ACL1-011, TAN-P8-681
Study First Received: February 6, 2009
Results First Received: June 22, 2010
Last Updated: April 24, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on April 17, 2014