A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered Once Daily) and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily) at Steady State

Labopharm Inc.0 sites30 target enrollmentJanuary 2008

ConditionsHealthy Subjects Bioavailability Pharmacokinetics

InterventionsTrazodone HCl

DrugsTrazodone HCl

Overview

Phase: Phase 1
Intervention: Trazodone HCl
Conditions: Healthy Subjects
Sponsor: Labopharm Inc.
Enrollment: 30
Primary Endpoint: Bioequivalence Based on Cmax,ss
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

March 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Labopharm Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects 18 to \<56 years of age.
•Body mass within 10% of ideal mass in relation to height and age, according to Body Mass Index.
•Body mass not less than 60 kg.
•Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
•Normal electrocardiogram (ECG) and vital signs, or abnormalities which the investigator did not consider a disqualification for participation in the study.
•Willingness to undergo pre- and post-study physical examinations and laboratory investigations.
•Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
•Non-smoker or past smoker who stopped the use of any form of tobacco, including snuff or similar products, at least 3 months before entering the study.
•For females, the following conditions had to be met:
•had been surgically sterilized or undergone a hysterectomy, or

Exclusion Criteria

•Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
•History of, or current compulsive alcohol abuse (\>10 drinks weekly), or regular exposure to other substances of abuse.
•Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not affect the outcome of the study in the opinion of the investigator.
•Participation in another study with an experimental drug, where the last administration (of previous study medication) was within 8 weeks before the first administration of study medication.
•Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
•A major illness during the 3 months before commencement of the screening period.
•History of hypersensitivity to the study medication or any related medication.
•History of bronchial asthma.
•History of epilepsy.
•History of porphyria.

Arms & Interventions

Trazodone HCl OAD

OAD: Once A Day

Intervention: Trazodone HCl

Trazodone HCl (Apotex Corp.)

Intervention: Trazodone HCl

Outcomes

Primary Outcomes

Bioequivalence Based on Cmax,ss

Time Frame: 9 days

Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).

Bioequivalence Based on AUCss

Time Frame: 9 days

AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss. Measured in nanograms x hours per milliliter (ng\*h/mL).