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

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

Overview[ - collapse ][ - ]

Purpose	The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations
Condition	Healthy
Intervention	Drug: Trazodone HCl Drug: Trazodone HCl
Phase	Phase 1
Sponsor	Labopharm Inc.
Responsible Party	Labopharm Inc.
ClinicalTrials.gov Identifier	NCT00839072
First Received	February 6, 2009
Last Updated	April 24, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	February 6, 2009
Last Updated Date	April 24, 2012
Start Date	February 2009
Estimated Primary Completion Date	March 2009
Current 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
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers
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
Brief 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.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: Trazodone HCl 100 mg immediate-release tablet, dosing q8h Drug: Trazodone HCl 300 mg extended-release caplet, single dose Other Names: Oleptro
Study Arm (s)	Experimental: Trazodone Contramid OAD Active Comparator: Desyrel

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	24
Estimated Completion Date	March 2009
Estimated Primary Completion Date	February 2009
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00839072
Other Study ID Numbers	04ACL1-011
Has Data Monitoring Committee	No
Information Provided By	Labopharm Inc.
Study Sponsor	Labopharm Inc.
Collaborators	Algorithme Pharma Inc
Investigators	Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
Verification Date	April 2012

Locations[ + expand ][ + ]