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Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01415778
First received: August 11, 2011
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to investigate the bioequivalence of ICI176,334-1 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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -

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 maximum plasma concentration (Cmax) [ 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 time to Cmax (tmax) [ 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 area under the plasma concentration curve (AUC) [ 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 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 ]

Secondary Outcome Measures:
  • To assess the safety by assessment of adverse event [ Time Frame: Screening day up to 35 to 42 days (follow-up) ] [ Designated as safety issue: Yes ]
  • To assess the safety by assessment of vital signs [ Time Frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ]
  • To assess the safety by assessment of electrocardiograms (ECGs) [ Time Frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
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
Experimental: Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
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
Experimental: Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
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
Experimental: Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
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

Detailed Description:

Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01415778     History of Changes
Other Study ID Numbers: D6874L00025
Study First Received: August 11, 2011
Last Updated: May 29, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on November 20, 2014