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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

Page last updated: August 20, 2015

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