Bioequivalence of Bicalutamide New Formulation in Japan

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)

The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: ICI176,334-1; Drug: 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)

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the bioequivalence of ICI176,334-1 by assessment of Cmax (Maximum Concentration of drug).	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).	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	Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the safety by assessment of adverse event.	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.	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)	Subjects will be monitored for electrocardiograms(ECGs) prior to treatment and up to 42 -49 days (follow-up) after the last dose.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (ESTIMATE): August 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: safety; Bioequivalence; Casodex; bicalutamide; pharmacokinetics; Japanese; healthy subject
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: D6874L00012