Bioequivalence Study of Anastrozole 1 mg Tablet

Bioequivalence Study of CJ Anastrozole 1mg Tablet and Arimidex® 1 mg Tablet

The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ anastrozole 1 mg tablet

Detailed Description

This study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed new generation aromatase inhibitor (CJ anastrozole) with existing anastrozole formulation (Arimidex®) in healthy Korean volunteers. This study is designed as single-dose, randomized, double-blind, 2-way crossover trial. Participants were randomized to receive 1 mg of either the CJ anastrozole or Arimidex, followed by a 3-week washout period. And then the alternate formulation was administered. After 10-hour overnight fast drug was administered. For analysis of pharmacokinetic properties, including Cmax and AUClast, blood samples were obtained at 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours after drug administration.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteers in the age between 19 to 55 years old
• Subjects were neither congenital nor chronic diseases.
• Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.

Exclusion Criteria:

• Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS
• Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy)
• Current clinically significant disorder in history taking or physical examination
• Acute disease within 14 days preceding the first application of study medication
• Had an relevant allergic disease
• Had history of hypersensitivity to drugs or any food
• Positive for Hepatitis B antigen, Hepatitis C antibody, HIV antibody, or High Quality Syphilis Reagin Test
• Excessive caffeine, alcohol intake and smoker(caffeine>5 units/day, alcohol>3 units/day(1 unit = pure alcohol 10ml), cigarettes> 20 cigarettes /day)
• Subjects who excessive alcohol intake or drug which affect drug metabolism enzyme intake within 30 days preceding study
• History of drug abuse or positive for urinary testing of drugs abuse (amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc.)
• Has donated whole blood within 60days or apheresis within 14days preceding the first application of study medication
• Received other investigational drug within 60days preceding the first application of study medication
• Taken any herbal medicine within 30days, prescription medication within 14 days or over-the-counter drug (except for vitamins, minerals) within 10days preceding the first application of study medication (might affect this study or safety of subjects as judged by the investigator)
• Subjects could not eat ASAN MEDICAL CENTER standard meal or were unsuitable for this study as judged by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: HK inno.N Corporation
• Investigators: Principal Investigator: Hyeong-Seok Lim, MD, Asan Medical Center

Publications and helpful links

General Publications

• Noh YH, Ko YJ, Cho SH, Ghim JL, Choe S, Jung JA, Kim UJ, Jin SJ, Park HJ, Song GS, Lim HS, Bae KS. Pharmacokinetic comparison of 2 formulations of anastrozole (1 mg) in healthy Korean male volunteers: a randomized, single-dose, 2-period, 2-sequence, crossover study. Clin Ther. 2012 Feb;34(2):305-13. doi: 10.1016/j.clinthera.2012.01.008. Epub 2012 Jan 26.

Helpful Links

• U.S. FDA Resources

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 15, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Healthy subjects; bioequivalence; anastrozole; Antineoplastic Agents; Enzyme Inhibitors; Therapeutic Uses
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: CJ_ANS_B01