Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
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 capsules (test) versus Effexor® XR (reference) administered as the
      content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Members of the community at large.

          -  Subjects will be females and/or males, non-smokers, 18 years of age and older.

          -  Female subjects will be postmenopausal 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 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 greater than 30.0.

          -  History of significant alcohol abuse within 6 months of the screening visit or any
             indication of the regular use of more than 14 units of alcohol per week (1 unit is
             equal to 150 mL of wine, 360mL 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, crack)
             within 1 year of the screening visit.

          -  History of allergic reactions to venlafaxine.

          -  History of allergic reactions to heparin.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days
             prior to administration of the study medication.

          -  Use of an investigational drug or participation in an investigational study within 30
             days prior to administration of the study medication.

          -  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.

          -  Any history or presence of clinically significant neurological, endocrinal,
             cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic
             disease.

          -  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 exposure.

          -  Positive alcohol breath test at screening.

          -  Subjects who have used tobacco in any form within the 90 days preceding study drug
             administration.

          -  Any food allergies, intolerance, restriction, or special diet that, in the opinion of
             the medical sub-investigator, contraindicates the subject's participation in this
             study.

          -  Subjects who have had a depot injection or implant of any drug 3 months prior to
             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.

          -  Subjects who have consumed food or beverages containing grapefruit within 7 days prior
             to administration of the study medication.

          -  Subjects with clinically significant presence or history of raised intra-ocular
             pressure or at the risk of acute narrow angle glaucoma.

          -  Subjects who have dentures or braces.

          -  Intolerance to venipunctures.

          -  Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,
             diabetes, or psychosis will not be eligible for this study.

          -  Subjects who are unable to understand or unwilling to sign the Informed Consent Form.

          -  Subjects with the known presence of volume-depletion.

          -  Subjects predisposed to bleeding of the skin and mucous membrane (impaired platelet
             aggregation).

          -  Subjects with clinically significant history of seizures.

          -  Additional exclusion criteria for females only:

               -  Breastfeeding subjects.

               -  Positive urine pregnancy test screen at screening.