Bioequivalence Study of Anastrozole 1 mg Tablet

NCT01105299 | Completed DMC

• 1 other identifier: CJ_ANS_B01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

bioequivalence; anastrozole; Healthy subjects; Antineoplastic Agents; Therapeutic Uses; Enzyme Inhibitors

Interventions

CJ anastrozole 1 mg tablet DRUG

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• HK inno.N Corporation: collaborator

Related Publications (1)

• 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.

  PMID: 22281018 DERIVED

Related Links

• U.S. FDA Resources

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hyeong-Seok Lim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 16, 2010

Record last verified: 2010-04