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

NCT01039233 | Completed Phase 1 DMC

• 1 other identifier: 50013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Bioequivalency

Outcome Measures

Primary Outcomes (3)

• AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)

  144 hour

• AUC0-inf area under the concentration-time curve from time zero to infinity)

  144 hour

• Cmax (maximum observed concentration of drug substance in plasma)

  144 hour

Study Arms (2)

Bicalutamide 50 mg Tablet

EXPERIMENTAL

Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet

Casodex® 50 mg Tablet

ACTIVE COMPARATOR

Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet

Interventions

Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet DRUG

Bicalutamide 50 mg Tablet; Casodex® 50 mg Tablet

Eligibility Criteria

• Age: 20 Years - 73 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, non-smoker, 18 years of age and older;
• Capable of consent;
• BMI≥19.0 and \<30.0 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kremers Urban Development Company: lead
• Watson Laboratories, Inc.: collaborator

Study Sites (1)

SFBC Anapharm

Montreal, Quebec, H3X 2H9, Canada

Location

MeSH Terms

Interventions

bicalutamide; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Richard Larouche, M.D.

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: May 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: July 1, 2005
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

CA (1)