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

NCT01044706 | Completed Phase 1 Results DMC

• 1 other identifier: 50014
• 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 fed conditions.

Conditions

Healthy

Keywords

Bioequivalency

Outcome Measures

Primary Outcomes (2)

• AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)

  AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)

  144 hour

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

  maximum observed concentration of drug substance in plasma

  144 hour

Study Arms (2)

Bicalutamide 50 mg Tablet

EXPERIMENTAL

Bicalutamide 50 mg Tablet

Drug: Bicalutamide

Casodex® 50 mg Tablet

ACTIVE COMPARATOR

Casodex® 50 mg Tablet

Drug: Bicalutamide

Interventions

Bicalutamide DRUG

50 mg Oral Tablet

Also known as: Casodex®

Bicalutamide 50 mg Tablet; Casodex® 50 mg Tablet

Eligibility Criteria

• Age: 19 Years - 70 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.
• 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.

Sponsors & Collaborators

• Kremers Urban Development Company: lead
• Watson Pharmaceuticals: collaborator

Study Sites (1)

SFBC Anapharm

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

bicalutamide

Results Point of Contact

• Title: Bang Qian Xu, Ph.D., Director of Biopharmaceutics
• Organization: Kremers Urban Development Company

Bang.xu@ucb.com

812-523-5453

Study Officials

• Benoit Girard, M.D.

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: May 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: March 2, 2010
• Results First Posted: March 1, 2010

Record last verified: 2010-02

Locations

CA (1)