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Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01039233
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Sponsor:
Collaborator:
Watson Laboratories, Inc.
Information provided by:
Kremers Urban Development Company

Brief 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 fasting conditions

Condition or disease Intervention/treatment Phase
Bioequivalency Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Study Start Date : May 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bicalutamide 50 mg Tablet Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
Active Comparator: Casodex® 50 mg Tablet Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet



Primary Outcome Measures :
  1. AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) [ Time Frame: 144 hour ]
  2. AUC0-inf area under the concentration-time curve from time zero to infinity) [ Time Frame: 144 hour ]
  3. Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: 144 hour ]


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Ages Eligible for Study:   20 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039233


Locations
Canada, Quebec
SFBC Anapharm
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Kremers Urban Development Company
Watson Laboratories, Inc.
Investigators
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm

Responsible Party: Richard Larouche, M.D., Medical Director, sfbc Anapharm
ClinicalTrials.gov Identifier: NCT01039233     History of Changes
Other Study ID Numbers: 50013
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents