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Bioequivalence of Bicalutamide New Formulation in Japan

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416870
First Posted: August 15, 2011
Last Update Posted: January 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Condition Intervention Phase
Healthy Drug: ICI176,334-1 Drug: Casodex 80 mg tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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. ]
  • 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. ]
  • 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. ]

Enrollment: 102
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 1
34 subjects will receive ICI176,334-1without water
Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Experimental: Active 2
34 subjects will receive ICI176,334-1 with water
Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Experimental: Active 3
34 subjects will receive Casodex 80 mg tablet
Drug: Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01416870     History of Changes
Other Study ID Numbers: D6874L00012
First Submitted: August 12, 2011
First Posted: August 15, 2011
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Bioequivalence
pharmacokinetics
safety
bicalutamide
Casodex
Japanese
healthy subject

Additional relevant MeSH terms:
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents