- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01039233
Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions
December 23, 2009 updated by: Kremers Urban Development Company
Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3X 2H9
- SFBC Anapharm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 73 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bicalutamide 50 mg Tablet
|
|
ACTIVE_COMPARATOR: Casodex® 50 mg Tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Time Frame: 144 hour
|
144 hour
|
AUC0-inf area under the concentration-time curve from time zero to infinity)
Time Frame: 144 hour
|
144 hour
|
Cmax (maximum observed concentration of drug substance in plasma)
Time Frame: 144 hour
|
144 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (ACTUAL)
June 1, 2005
Study Completion (ACTUAL)
July 1, 2005
Study Registration Dates
First Submitted
December 23, 2009
First Submitted That Met QC Criteria
December 23, 2009
First Posted (ESTIMATE)
December 24, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 24, 2009
Last Update Submitted That Met QC Criteria
December 23, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bioequivalency
-
Center for Clinical Pharmacology Research Bdbeq...Laboratorio Elea Phoenix S.A.Unknown
-
Perrigo CompanyCompleted
-
Center for Clinical Pharmacology Research Bdbeq...Laboratorio Elea Phoenix S.A.UnknownBioequivalencyUruguay
-
Perrigo CompanyCompleted
-
Perrigo CompanyCompleted
-
Perrigo CompanyCompleted
-
Xcovery Holdings, Inc.CompletedBioequivalencyUnited States
Clinical Trials on Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
-
BayerAmgenCompleted
-
Cassava Sciences, Inc.National Institute on Aging (NIA)Completed
-
Chang Gung Memorial HospitalRecruitingThyroid Disease PregnancyTaiwan
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy VolunteersUnited States
-
Mutual Pharmaceutical Company, Inc.CompletedTherapeutic Equivalency
-
SandozCompleted
-
University of AlexandriaCompleted
-
SandozCompleted
-
World Medicine ILAC SAN. ve TIC. A.S.Novagenix Bioanalytical Drug R&D Center; Farmagen Ar-Ge Biyot. Ltd. StiCompleted
-
LG ChemCompleted