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

NCT00839072 | Completed Phase 1 Results

• 2 other identifiers: 04ACL1-011TAN-P8-681
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

bioavailability; pharmacokinetics; healthy; crossover; trazodone

Outcome Measures

Primary Outcomes (3)

• Bioequivalence Based on Cmax

  Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)

  72 hours post-dose

• Bioequivalence Based on AUCT

  AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration

  72 hours post-dose

• Bioequivalence Based on AUC∞

  AUC∞ = Area under the concentration-time curve extrapolated to infinity

  72 hours post-dose

Secondary Outcomes (3)

• Time of Maximum Measured Plasma Concentration (Tmax)

  72 hours post-dose

• Apparent Terminal Elimination Half-Life [T½el]

  72 hours post-dose

• Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]

  24 hours

Study Arms (2)

Trazodone Contramid OAD

EXPERIMENTAL

Drug: Trazodone HCl

Desyrel

ACTIVE COMPARATOR

Drug: Trazodone HCl

Interventions

Trazodone HCl DRUG

100 mg immediate-release tablet, dosing q8h

Desyrel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Labopharm Inc.: lead
• Algorithme Pharma Inc: collaborator

Study Sites (1)

Algorithme Pharma Inc.

Laval, Quebec, H7V 4B3, Canada

Location

MeSH Terms

Interventions

Trazodone

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 27, 2012
• Results First Posted: August 16, 2010

Record last verified: 2012-04

Locations

CA (1)