Bioequivalence of Bicalutamide New Formulation in Japan

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01416870

First received: August 12, 2011

Last updated: January 10, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 12, 2011
Last Updated Date	January 10, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 12, 2011)	To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug). [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ] To investigate the bioequivalence of ICI176,334-1 by assessment of AUC (concentration Area Under the Curve). [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ] To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 (half time) of bicalutamide [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01416870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 12, 2011)	To assess the safety by assessment of adverse event. [ Time Frame: Subjects will be monitored for adverse events prior to treatment and up to 42 -49 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ] To assess the safety by assessment of vital signs. [ Time Frame: Subjects will be monitored for vital signs prior to treatment and up to 42 -49 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ] To assess the safety by assessment of electrocardiograms (ECGs) [ Time Frame: Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioequivalence of Bicalutamide New Formulation in Japan
Official Title ^ICMJE	Bioequivalence Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex Tablet (80mg)
Brief Summary	The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
Detailed Description	Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: ICI176,334-1 Subject will receive single dose of ICI176,334-1 Drug: Casodex 80 mg tablet Subject will receive single dose of Casodex 80 mg tablet
Study Arm (s)	Experimental: Active 1 34 subjects will receive ICI176,334-1without water Intervention: Drug: ICI176,334-1 Experimental: Active 2 34 subjects will receive ICI176,334-1 with water Intervention: Drug: ICI176,334-1 Experimental: Active 3 34 subjects will receive Casodex 80 mg tablet Intervention: Drug: Casodex 80 mg tablet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	102
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 17 and 27 kg/m2 Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s) Exclusion Criteria: Presence of any disease under medical treatment History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s) Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation
Gender	Male
Ages	20 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01416870
Other Study ID Numbers ^ICMJE	D6874L00012
Has Data Monitoring Committee	Not Provided
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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