Venlafaxine 25 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Venlafaxine 25 mg Tablets; Effexor® 25 mg Tablets
Intervention description: 1 x 25 mg, single-dose fasting; 1 x 25 mg, single-dose fasting
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the rate and extent of absorption of venlafaxine 25
      mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be females and/or males, non-smokers, 18 years of age and older. Female
             subjects will be post-menopausal or surgically sterilized.

          -  Post-menopausal status is defined as absence of menses for the past 12 months or
             hysterectomy with bilateral oophorectomy at least 6 months ago.

          -  Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at
             least 6 months ago.

        Exclusion Criteria:

          -  Clinically significant illnesses within 4 weeks of the administration of study
             medication.

          -  Clinically significant surgery within 4 weeks of the administration of 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 (systolic blood
             pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or
             over 90 mmHg; or heart rate less than 50 or over 100 bpm) 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, phencyclidine
             (PCP) and 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 (examples of
             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;
             examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,
             ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) 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 (e.g.
             chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms
             (e.g. diarrhea, vomiting), 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 (including natural food supplements, vitamins,
             garlic as a supplement) within 7 days prior to administration of study medication,
             except for topical products without systemic absorption.

          -  Positive alcohol breath test at screening.

          -  Subjects who have used tobacco in any form within the 90 days preceding study drug
             administration.

          -  Intolerance to venipuncture.

          -  Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,
             diabetes, psychosis, or glaucoma will not be eligible for this study.

          -  Subjects who are unable to understand or unwilling to sign the Informed Consent Form.

          -  Any food allergy, 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 an 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 (e.g. fresh,
             canned, or frozen) within 7 days prior to administration of the study medication.

          -  Subjects with known presence of volume-depletion.

          -  Subjects predisposed to bleeding of the skin and mucous membrane.

          -  Subjects with history or known presence of impaired platelet aggregation.

          -  Subjects with history of seizures.

          -  Breast-feeding subjects.

          -  Positive urine pregnancy test at screening (performed on all females).