Healthy
Conditions
Keywords
Bioequivalency
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.
Interventions
DRUGBicalutamide
50 mg Oral Tablet
Sponsors
Watson Pharmaceuticals
Kremers Urban Development Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 144 hour | maximum observed concentration of drug substance in plasma |
| AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose) | 144 hour | AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose) |
Countries
Canada
Participant flow
Recruitment details
healthy subjects recruited in April 2005 by sfbc Anapharm at 2050, Boul. Rene-Levesque Quest, Saint-Foy, Quebec, Canada G1V 2K8
Pre-assignment details
This was a single center, bioequivalence, open-label, single-dose, 1-way parallel study
Participants by arm
| Arm | Count |
|---|---|
| Bicalutamide 50 mg Tablet Bicalutamide 50 mg Tablet | 30 |
| Casodex® 50 mg Tablet Casodex® 50 mg Tablet | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Casodex® 50 mg Tablet | Bicalutamide 50 mg Tablet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age Continuous | 37.93 years STANDARD_DEVIATION 14.41 | 40.13 years STANDARD_DEVIATION 14.1 | 39.03 years STANDARD_DEVIATION 14.18 |
| Region of Enrollment Canada | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 30 | 18 / 30 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Time frame: 144 hour
Population: per protocol
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bicalutamide 50 mg Tablet | AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose) | 114386.56 ng*h/mL | Standard Deviation 14285.37 |
| Casodex® 50 mg Tablet | AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose) | 105377.55 ng*h/mL | Standard Deviation 11989.86 |
Comparison: Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.p-value: <0.0590% CI: [102.79, 114.44]ANOVA
Primary
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
maximum observed concentration of drug substance in plasma
Time frame: 144 hour
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bicalutamide 50 mg Tablet | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 1253.60 ng/mL | Standard Deviation 138.02 |
| Casodex® 50 mg Tablet | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 1134.86 ng/mL | Standard Deviation 122.44 |
Comparison: Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.p-value: <0.0595% CI: [105.43, 115.82]ANOVA