Trial Outcomes & Findings for Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions (NCT NCT01044706)

NCT ID: NCT01044706

Last Updated: 2010-03-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: 144 hour
• Results posted on: 2010-03-02

Participant Flow

healthy subjects recruited in April 2005 by sfbc Anapharm at 2050, Boul. Rene-Levesque Quest, Saint-Foy, Quebec, Canada G1V 2K8

This was a single center, bioequivalence, open-label, single-dose, 1-way parallel study

Participant milestones

Measure	Bicalutamide 50 mg Tablet Bicalutamide 50 mg Tablet	Casodex® 50 mg Tablet Casodex® 50 mg Tablet
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bicalutamide 50 mg Tablet n=30 Participants Bicalutamide 50 mg Tablet	Casodex® 50 mg Tablet n=30 Participants Casodex® 50 mg Tablet	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	40.13 years STANDARD_DEVIATION 14.10 • n=5 Participants	37.93 years STANDARD_DEVIATION 14.41 • n=7 Participants	39.03 years STANDARD_DEVIATION 14.18 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Canada	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 144 hour

Population: per protocol

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

Outcome measures

Measure	Bicalutamide 50 mg Tablet n=30 Participants Bicalutamide 50 mg Tablet	Casodex® 50 mg Tablet n=30 Participants Casodex® 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	105377.55 ng*h/mL Standard Deviation 11989.86

PRIMARY outcome

Timeframe: 144 hour

maximum observed concentration of drug substance in plasma

Outcome measures

Measure	Bicalutamide 50 mg Tablet n=30 Participants Bicalutamide 50 mg Tablet	Casodex® 50 mg Tablet n=30 Participants Casodex® 50 mg Tablet
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	1253.60 ng/mL Standard Deviation 138.02	1134.86 ng/mL Standard Deviation 122.44

Adverse Events

Bicalutamide 50 mg Tablet

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Casodex® 50 mg Tablet

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bicalutamide 50 mg Tablet n=30 participants at risk Bicalutamide 50 mg Tablet	Casodex® 50 mg Tablet n=30 participants at risk Casodex® 50 mg Tablet
Gastrointestinal disorders Dry mouth	0.00% 0/30	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Dyspepsia	0.00% 0/30	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Pain abdomen	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1
General disorders Asthenia	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1
General disorders Pruritus	3.3% 1/30 • Number of events 1	0.00% 0/30
Injury, poisoning and procedural complications Ecchymosis	6.7% 2/30 • Number of events 2	6.7% 2/30 • Number of events 2
Injury, poisoning and procedural complications Edema inject site	3.3% 1/30 • Number of events 1	6.7% 2/30 • Number of events 2
Injury, poisoning and procedural complications Hysn inject site	0.00% 0/30	3.3% 1/30 • Number of events 1
Musculoskeletal and connective tissue disorders Cramp leg	3.3% 1/30 • Number of events 1	0.00% 0/30
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/30	3.3% 1/30 • Number of events 1
Musculoskeletal and connective tissue disorders Pain back	3.3% 1/30 • Number of events 1	6.7% 2/30 • Number of events 2
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1
Nervous system disorders Headache	3.3% 1/30 • Number of events 1	0.00% 0/30
Nervous system disorders Somnolence	0.00% 0/30	3.3% 1/30 • Number of events 1
Psychiatric disorders Insomnia	0.00% 0/30	3.3% 1/30 • Number of events 1
Renal and urinary disorders Urine frequency	0.00% 0/30	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Rash	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/30	3.3% 1/30 • Number of events 1

Additional Information

Bang Qian Xu, Ph.D., Director of Biopharmaceutics

Kremers Urban Development Company

Phone: 812-523-5453

Email: Bang.xu@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee This document contains trade secrets and commercial information that is confidential and may not be disclosed to third parties. Persons to whom this study protocol is disclosed must be informed that all the information herein is confidential and may not be further divulged. These restrictions will apply as well to all future communications if deemed privileged or confidential. Publication of the study results may only be allowed with written permission from the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER