Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions
Condition: Healthy
Intervention: Venlafaxine Hydrochloride; Effexor® XR
Intervention description: 150 mg Extended-Release Capsule; 150 mg Extended-Release Capsule
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study was to compare the rate and extent of absorption of venlafaxine
      hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference)
      administered as 1 x 150 mg extended-release capsule under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Members of the community at large.

          -  Subjects will be females and/or males, non-smokers, 18 years or age and older.

          -  Female subjects will be post-menopausal or surgically sterilized.

        Exclusion Criteria:

          -  Clinically significant illness within 4 weeks of the administration of study
             medication.

          -  Clinically significant surgery within 4 weeks prior to the administration of the study
             medication.

          -  Any clinically significant abnormality found during medical screening.

          -  Any history or presence of significant neurological, endocrinal, cardiovascular,
             pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

          -  History or presence of any clinically significant gastrointestinal pathology,
             unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions
             known to interfere with the absorption, distribution, metabolism, or excretion of the
             drug.

          -  Subjects with raised intra-ocular pressure or at risk of acute narrow angle glaucoma.

          -  Subjects predisposed to bleeding of the skin and mucous membrane.

          -  Subjects with a history of seizures.

          -  Any reason which, in the opinion of the medical sub-investigator, would prevent the
             subject from participating in the study.

          -  Abnormal laboratory tests judged clinically significant.

          -  Positive urine drug screen at screening.

          -  Positive testing for hepatitis B, hepatitis C, or HIV at screening.

          -  ECG abnormalities (clinically significant) or vital sign abnormalities at screening.

          -  Subjects with BMI > 30.0.

          -  History of significant alcohol abuse within six months of the screening visit or any
             indication of the regular use of more than fourteen units of alcohol per week (1 unit
             = 150 mL of wine, or 360 mL of beer, or 45 mL of alcohol 40%).

          -  History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)
             within 3 months of the screening visit or hard drugs (such as cocaine, PCP, and crack)
             within 1 year of the screening visit.

          -  Any food allergy, intolerance, restriction, or special diet that, in the opinion of
             the medical sub-investigator, contraindicates the subject's participation in the
             study.

          -  History of allergic reaction to venlafaxine hydrochloride.

          -  History of allergic reaction to heparin.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism, use of any
             investigational drug, or participation in an investigational study within 30 days
             prior to administration of the study medication.

          -  Use of prescription medication within 14 days prior to administration of study
             medication or over-the-counter products within 7 days prior to administration of study
             medication, except for topical products without systemic absorption.

          -  Subjects who have had a depot injection or an implant of any drug 3 months prior to
             the administration of study medication.

          -  Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to
             administration of the study medication as follows:

               -  less than 300 mL of whole blood within 30 days, or

               -  300 mL to 500 mL of whole blood within 45 days, or

               -  more than 500 mL of whole blood within 56 days.

          -  Positive alcohol breath test at screening.

          -  Subjects who have used tobacco in any form within the 90 days preceding study drug
             administration.

          -  Subjects who have consumed food or beverages containing grapefruit within 7 days prior
             to administration of the study medication.

          -  Intolerance to venipunctures.

          -  Additional exclusion criteria for females only:

               -  Breast-feeding subjects.

               -  Positive urine pregnancy test at screening.