Bioequivalence of Bicalutamide New Formulation in Japan

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01416870
• Other study ID #: D6874L00012
• Status: Terminated
• Phase: Phase 1
• First received: August 12, 2011
• Last updated: January 10, 2012
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ICI176,334-1
Subject will receive single dose of ICI176,334-1
• Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes