Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Safety; Pharmacokinetics
Intervention: Anastrozole ODF (Drug); Arimidex tablet (Drug); Anastrozole ODF (Drug); Arimidex tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Eisei Shin, MD, Study Director, Affiliation: AstraZeneca R&D Japan Kyoko Matsuguma, MD PhD, Principal Investigator, Affiliation: Kyushu Clinical Pharmacology Research Clinic
Summary
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet
after a single oral administration of each anastrozole formulation.
Clinical Details
Official title: A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
Secondary outcome: Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.
Detailed description:
A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing
Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After
Single Oral Administration in Japanese Healthy Male Subjects
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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 18 and 27 kg/m2
Exclusion Criteria:
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion
of drugs Any clinically significant illness, medical/surgical procedure or trauma
- Any clinically significant abnormalities in clinical chemistry, haematology or
urinalysis results
Locations and Contacts
Research Site, Fukuoka, Japan
Additional Information
Starting date: April 2012
Last updated: June 22, 2012
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