Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Bicalutamide
Intervention description: 50 mg Oral Tablet
Intervention MeSH terms: Bicalutamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalency

Summary:

      The objective of this study is to compare the rate and extent of absorption of bicalutamide
      50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, non-smoker, 18 years of age and older;

          -  Capable of consent;

          -  BMI≥19.0 and <30.0 kg/m2.

        Exclusion Criteria:

          -  Clinically significant illnesses within 4 weeks prior to the administration of the
             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 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, diastolic blood pressure lower than 50 or
             over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.

          -  History of significant alcohol abuse or drug abuse within one year prior to the
             screening visit.

          -  Regular use of alcohol within six months prior to the screening visit (more than
             fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL
             of 40% alcohol]).

          -  Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or
             hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the
             screening visit or positive urine drug screen at screening.

          -  History of allergic reactions to heparin, bicalutamide, or other related drugs.

          -  Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of
             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole;
             examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides,
             imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) 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.

          -  Clinically significant 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 clinically significant 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.

          -  Difficulty to swallow study medication.

          -  Use of any tobacco products in the 6 months preceding drug administration.

          -  Any food allergy, intolerance, restriction or special diet that, in the opinion of the
             Medical Sub-Investigator, could contraindicate the subject's participation in this
             study.

          -  A depot injection or an implant of any drug within 3 months prior to administration of
             study medication.

          -  Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or
             loss of whole blood (excluding the volume of blood that will be drawn during the
             screening procedures of this study) prior to administration of the study medication as
             follows:

               -  50 mL to 300 mL of whole blood within 30 days,

               -  301 mL to 500 mL of whole blood within 45 days, or

               -  more than 500 mL of whole blood within 56 days prior to drug administration.