Bioequivalence Study of Anastrozole 1 mg Tablet

Asan Medical Center

Status

Completed

Conditions

Healthy

Treatments

Drug: CJ anastrozole 1 mg tablet

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01105299

CJ_ANS_B01

Details and patient eligibility

About

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].

Full 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.

Enrollment

24 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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