Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers
Condition: Healthy
Intervention: Trazodone HCl; Trazodone HCl
Intervention description: 100 mg immediate-release tablet, dosing q8h; 300 mg extended-release caplet, single dose
Intervention MeSH terms: Trazodone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioavailability; pharmacokinetics; healthy; crossover; trazodone

Summary:

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

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